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Finance Specialist jobs in Ireland

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316 jobs found
Yesterday
WP

West Pharma Senior Specialist Quality Engineer Ireland, Waterford

Limitless High-tech career opportunities - Expoint
Degree in a Quality, Science or Engineering or equivalent discipline.Desired:Quality Auditing certification.Lean/Six Sigma certification.Supervisory experience. Quality Auditing certification. Lean/Six Sigma certification. Supervisory experience....
Description:




Job Summary

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

Essential Duties and Responsibilities

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required


Basic Qualifications
  • Degree in a Quality, Science or Engineering or equivalent discipline.

    Desired:

    • Quality Auditing certification.
    • Lean/Six Sigma certification.
    • Supervisory experience.
Preferred Knowledge, Skills and Abilities

• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target

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21.11.2025
WP

West Pharma Senior Specialist Supplier Quality Ireland, Waterford

Limitless High-tech career opportunities - Expoint
Establish and successfully executesupplier management planswhich will align to overall business objectives. Maintain a strong collaborativepartnership. supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action...
Description:
Job Summary

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

Essential Duties and Responsibilities
  • Establish and successfully executesupplier management planswhich will align to overall business objectives

  • Maintain a strong collaborativepartnership

Additional Responsibilities
  • supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

  • ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

  • Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

  • Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

  • Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

  • Approves components for use in products by drivingProduct Approvalactivities with the suppliers

  • Supports Supplier evaluation,auditmanagement and related records

  • Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

  • Support the development of anIncoming Inspection strategyon purchased products


Education
  • Bachelor's Degree In Engineering or Science required
  • Master's Degree In Engineering or Science preferred
Work Experience
  • Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry
  • Experience working with suppliers and supplier engagement activities

Preferred Knowledge, Skills and Abilities
  • Knowledge of sterilization process is preferred

  • Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

  • Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

  • Fluent in English

  • Thorough understanding of validation activities and risk management principles and techniques

  • Strong problem-solving and critical thinking skills

  • Negotiation skills and collaborating with suppliers

  • Ability to work under high volume production and fast changing environment

  • Willingness to work in a cross-functional team with different time zones

  • Able to comply with the company’s safety policy at all times.
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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21.11.2025
WP

West Pharma Senior Manager Digital Business Integration Finance Ireland, Dublin

Limitless High-tech career opportunities - Expoint
Identify deployment site requirements and solutions within our global SAP template; define gaps and design solutions, with the support of system architects, where required. Train new users in global processes...
Description:
Essential Duties and Responsibilities
  • Identify deployment site requirements and solutions within our global SAP template; define gaps and design solutions, with the support of system architects, where required
  • Train new users in global processes in coordination with Subject Matter Experts
  • Coordinate and support the execution of user acceptance testing and data conversion validation
  • Lead workshops and interviews with Subject Matter Experts to identify transformation opportunities
  • Manage the transformation portfolio within the Agile framework, linking opportunities to leadership priorities
  • Develop, track, and report metrics to articulate change benefit realization
  • Lead both direct reports and subject matter experts who work in other departments and functions
  • Collaborate with Digital & Transformation team to design and implement resilient business processes enabled by supporting technologies
  • Define and communicate change impacts to Finance processes, systems, and structures, and support peer leaders to drive stakeholder engagement, communication, and acceptance of change
  • Other duties as assigned
Education
  • Bachelor’s degree in Accounting, Information Systems, or related fields, or equivalent experience
Work Experience
  • Minimum 10 years of experience in project execution, process design, and/or systems implementation
  • Experience with SAP (S/4HANA preferred), specifically with Financial Accounting and Controlling modules
Preferred Knowledge, Skills and Abilities
  • Strong knowledge of and experience with leading practice budgeting, forecasting, analytics, and accounting principles for the typical business processes of a Life Sciences manufacturing company (Order to Cash, Procure to Pay, Record to Report, etc.)
  • Ability to manage change effectively, including strong interpersonal communication skills that can be adapted to various levels of the organization
  • Experience with Agile project management framework, and ability to set goals, create sprint plans, track progress, and hold team members accountable for timely delivery
  • Experience and/or training in Generative Artificial Intelligence and Machine Learning, SAP BW/BI, Microsoft Power BI, and other tools in the Microsoft Power Platform or similar tools for process automation
  • Ability to lead cross-functional teams collaboratively, encouraging resilience and maintaining a positive mindset
  • Comfort with ambiguity and the ability to logically structure issues and recommend best practice solutions
  • Mindset focused on continuous learning to maintain knowledge of industry trends, new technologies, and evolving best practices
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
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19.11.2025
EY

EY UKI Business Consulting - Finance Transformation Ireland

Limitless High-tech career opportunities - Expoint
Performing current-state diagnostics. Developing a vision, strategy, and operating model. Delivering an activity analysis, and creating a business case. Crafting an integrated implementation roadmap. Guiding location and sourcing model selection....
Description:

Dublin / Belfast

Contract Type:Full-Time – Permanent

A growth area for us is Global Business Services, and how technology enables control– supporting companies in either taking their first steps to establish their Global Business Services capability or developing the maturity of existing Finance and GBS organisations. We support our clients across the full lifecycle of the transformation journey, including:

  • Performing current-state diagnostics
  • Developing a vision, strategy, and operating model
  • Delivering an activity analysis, and creating a business case
  • Crafting an integrated implementation roadmap
  • Guiding location and sourcing model selection
  • Designing and implementing future state processes and technologies (particularly across record-to-report, order-to-cash, procure-to-pay, as well as identifying AI opportunities)
  • Shaping future organisation design
  • Overseeing transition to future models
  • Designing and implementing experience-led service management
  • All encompassed by end-to-end programme management

Your key responsibilities

You will build strong relationships within client organisations, working with them to understand their most critical business problems and priorities, consulting with your EY peers to evaluate, design, and deliver solution options that leverage cutting-edge technologies.

Skills and attributes for Success

Professional in your approach, you will have a natural ability to establish personal credibility with clients. You will also be highly organised, capable of coordinating your own workload and that of other team members, meeting deadlines, proactively managing risks and delivering quality outcomes.

A role model to those around you, you will live the values of the firm daily, coaching and supporting the development of others.

You will add measurable value to your clients by delivering work that addresses their biggest challenges and priorities, including the need to:

  • Conduct diagnostic activities to assess maturity of processes, technology, and people
  • Develop future-state Finance and/or GBS vision, strategy, and high-level operating model
  • Create a Finance and/or GBS transformation business case
  • Assess potential locations for Finance and/or GBS centres
  • Design future-state Finance and/or GBS and retained processes and organisation (including PTP, OTC and RTR)
  • Develop a transformation implementation roadmap
  • Implement the future-state processes and technologies
  • Manage transition of activities into new locations (e.g. knowledge transfer)
  • Lead design and implementation of new processes and organisation structures; being able to identify opportunities for technology
  • Establish best-in-class service management practices and governance structures

To qualify for the role, you must have:

  • 6+ years relevant experience
  • Experience in designing solutions forGlobal Business Services
  • Implementation experience ofGlobal Business Servicessolutions
  • Proficiency in your chosen market or sector
  • Strong client relationship skills and proven stakeholder engagement
  • A keen interest in applying modern technologies to solve Finance and cross-functional challenges

Ideally, you'll also have:

  • A valid and certified professional accounting qualification
  • A background in management consulting or experience leading large-scale services transformation
  • High attention to detail and strong output quality
  • Strong facilitation, presentation, and analytical problem-solving skills
  • Experience line managing and coaching high-performing teams.
  • Experience in the design and implementation of best-in-class Service Management (including service management tools and performance management frameworks)
  • Experience facilitating the planning, delivery and management of services, ensuring client requirements and specifications are achieved
  • Understanding or application of relevant technologies such as:
    • Service Management Tools
    • GenAI and Agentic AI
    • Accounting Automation
    • Consolidation and Reporting Tools

What we look for

  • Core consulting skills: client management, commercial thinking, problem solving, and facilitation
  • Technical skills: hands-on delivery experience and subject-matter knowledge in Finance transformation and performance improvement
  • Versatility: ability to adapt quickly and contribute in a fast-changing, tech-enabled environment
  • Market / sector knowledge: demonstrable domain expertise relevant to your field

We offer a competitive remuneration package. Our comprehensive Total Rewards package includes support for flexible working and career development, and with FlexEY you can select benefits that suit your needs, covering holidays, health and well-being, insurance, savings and a wide range of discounts, offers and promotions. Plus, we offer:

  • upport and coaching from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you

All our employees are given a benefits package which they can tailor to suit their individual preferences. Our range of benefits include:

  • Pension
  • Maternity & Paternity leave
  • Discounted health insurance
  • Bike to work Scheme
  • Web Doctor - Free unlimited online GP consultations for you and your family
  • Recognition Awards
  • The purchase of additional annual leave
  • Cash incentives for referrals
  • Hybrid Working
  • Work Mobile
  • Free Gym membership
  • TECH MBA paid by EY
  • Travel Pass
  • Wellness rooms Available in some offices

Career Progression

  • When you join EY, you will be supported to ensure that you are enhancing your skills from day one.
  • Continuous learning, where you can develop the mindset and skills to navigate whatever comes next.
  • As you grow and develop here, you’ll discover opportunities to help customise your career journey, so that it’s as unique as you are - success is defined by you, we will provide the tools and flexibility, so you can make a meaningful impact, your way.
  • Transformative leadership, we will give you the insights, coaching and confidence to be the leader the world needs.
  • Diverse and inclusive culture, you will be embraced for who you are and empowered to use your voice to help others find theirs.
  • We have embraced Hybrid working at EY adding greater flexibility and autonomy to the roles of our employees.

Inclusion & Diversity

We hold a collective commitment to foster an environment where all differences are valued and respected, practices are equitable and everyone experiences a sense of belonging: Inclusion, diversity, and equity are part of who we are at EY. We believe that the highest-performing teams maximize the power of different perspectives and backgrounds. These teams are both diverse and inclusive and are willing to invite and learn from other perspectives. Our ability to include various viewpoints into our mindsets, behaviours and operations is fundamental to driving innovation, building strong relationships, and delivering the best solutions for our clients.

We recognise the strength that comes from having a diverse workforce and building a culture where we support all our people to achieve their potential. You’ll be embraced for who you are and empowered to use your voice to help others find theirs.



EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.

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19.11.2025
BOA

Bank Of America Senior Fulfilment Specialist Ireland, Dublin

Limitless High-tech career opportunities - Expoint
Project managing the implementation of treasury solutions with new and existing clients to Bank of America - covering core product solutions / service offerings. Working in partnership with the client...
Description:

Role Description:

Whether you’re already working within Treasury Management or have had exposure to electronic operational cash management - if you’re a client professional looking to develop a career in banking then we’d love to hear from you. We’re particularly interested in those with stakeholder management skills and who are used to working in a fast-paced environment.

Responsibilities:

• Project managing the implementation of treasury solutions with new and existing clients to Bank of America - covering core product solutions / service offerings

• Working in partnership with the client to create and agree an implementation delivery timeline, clearly communicate the project status; identify issues, resolution steps and deadlines

• Coordinating with internal Business Partners as necessary

• Attending conference calls where specific cash management and client knowledge will assist with the execution of the solution

• Providing support and guidance to Sales Officers where required/requested during the sales process

• You will have an extensive number of years experience within a project management role

• Being able to demonstrate extensive experience with client facing roles, both orally and written, preferably within a similar client servicing function.

• Experience dealing with corporate clients at all levels in a positive and professional manner, with the ability to work under pressure

• Experience in Treasury Management products

• Project management/process coordination experience concentrating on cash management solutions for corporate organisations, including exposure to elements such as electronic payments, SWIFT messaging, BACS, CHAPS, Foreign Exchange (FX) and Money Markets (MM)

Skills that will help:

• Self motivating, flexible, and able to work independent of direct supervision

• Problem solving/analytical and organizational skills

• General PC, Windows and Excel Knowledge

• Private healthcare for you and your family plus an annual health screen to help you manage your physical wellness with the option to purchase a screen for your partner.

• Competitive pension plan, life assurance and group income protection cover if you become unable to work as a result of a disability or health reasons.

• We offer 26-weeks paid maternity leave, 16-weeks paid paternity leave and inclusive family leave arrangements for working parents and carers including 20 days of back-up childcare including access to school holiday clubs and 20 days of back-up adult care per annum.

• The ability to change your core benefits as well as the option of selecting a variety of flexible benefits to suit your personal circumstances including access to a wellbeing account, travel insurance, critical illness, cycle to work, TaxSaver tickets etc.

• Access to an Employee Assistance Program for confidential support and help for everyday matters.

• Access to free counselling through the Employee Assistance Program and virtual GP services through our private health care plan.

• Ability to donate to charities of your choice and the bank will match your contribution.

• Opportunity to access our Arts & Culture corporate membership program and receive discounted entry to some of Ireland’s most iconic cultural institutions and exhibitions.

• Opportunity to give back to your community, develop new skills and work with new groups of people by volunteering in your local community.

We strive to ensure that our recruitment processes are accessible for all candidates and encourage any candidates to tell us about any adjustment requirements.

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19.11.2025
EY

EY UKI Business Consulting - Finance Transformation Senior Cons... Ireland

Limitless High-tech career opportunities - Expoint
Exercise judgment in selecting methods, techniques, and evaluation criteria for delivering results. Develop solutions to complex problems and recommend policy or procedural changes as needed. Be accountable for the budget,...
Description:

This role requires strong strategic thinking, communication skills, and the ability to address complex organizational challenges with fit-for-purpose solutions. You will also support business development efforts and advise senior client stakeholders on transformation strategies aligned with sector trends and operational priorities.

You will be embedded within one or more strategic accounts, serving as a transformation architect responsible for shaping integrated, cross-functional solutions across domains such as wells, operations, supply chain, emissions, and enterprise functions. A key focus will be on elevating go-to-market maturity by aligning initiatives, identifying synergies, and influencing both design-time and delivery-time decisions.

Your key responsibilities

As a Senior Manager, you will oversee the effective management and delivery of complex processes, solutions, and projects—ensuring quality, managing risk, and contributing to business growth. You will:

  • Exercise judgment in selecting methods, techniques, and evaluation criteria for delivering results.
  • Develop solutions to complex problems and recommend policy or procedural changes as needed.
  • Be accountable for the budget, execution, and performance of transformation initiatives.
  • Lead pursuit efforts including proposal development, team structuring, commercial approach, and use of EY accelerators.
  • Serve as a transformation architect across priority accounts, integrating workstreams to drive account-wide value.
  • Shape go-to-market and account strategies by aligning business priorities, solution assets, and strategic partners.

Skills and attributes for success

To thrive in this role, you will need strong expertise in transformation architecture, including the ability to analyze, problem-solve, and apply best practices to deliver business impact. You will also:

  • Lead engagement delivery and program management.
  • Manage senior client relationships through day-to-day and executive-level interactions.
  • Drive business development pursuits and prepare proposals.
  • Travel as needed to support client delivery.

To qualify for the role, you must have

  • A bachelor’s degree (required), master’s preferred.
  • At least 8 years of relevant experience in business transformation, with deep sector expertise in oil and gas.
  • Proven experience in:
    • Operating model design and deployment
    • Transformation strategy and business case development
    • Portfolio governance, performance metric design, and cost transformation
    • Agile organization development and digital strategy
    • Familiarity with emerging technologies and future-back planning
  • Strong foundational business skills, including:
    • Client relationship management and trust-building
    • Commercial acumen and proposal development
    • Executive-level communication and change leadership
    • Systems thinking, sustainability, and cross-functional team leadership

Ideally, you’ll also have

  • Experience navigating complex stakeholder environments.
  • Demonstrated leadership and ability to inspire teams.
  • Excellent communication and interpersonal skills.
  • Experience delivering transformation strategies at an account or enterprise level.
  • Familiarity with technologies used in upstream and integrated operations
  • Experience coordinating solution design and delivery across teams and ecosystem partners.

What we offer you
At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn .

  • We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $150,400 to $343,600. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $180,500 to $390,500. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.
  • Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.
  • Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being.


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19.11.2025
EY

EY UKI Business Consulting - Finance Transformation Senior Mana... Ireland

Limitless High-tech career opportunities - Expoint
Leading client engagements and managing diverse teams to deliver high-quality outcomes. Building and maintaining long-term client relationships across EY practices. Driving delivery of finance transformation projects including operating models, shared...
Description:

Your key responsibilities

  • Leading client engagements and managing diverse teams to deliver high-quality outcomes.
  • Building and maintaining long-term client relationships across EY practices.
  • Driving delivery of finance transformation projects including operating models, shared services, and finance technologies.
  • Monitoring project progress, managing risks, and ensuring stakeholder alignment.
  • Mentoring junior consultants and fostering an inclusive, innovative team environment.
  • Staying current on industry trends and emerging technologies to support client needs.

Skills and attributes for Success

  • Strong consulting background with experience in finance reporting, process automation, and transformation.
  • Proven ability to manage senior stakeholders and deliver strategic advice.
  • Experience across the full lifecycle of transformation projects.
  • Excellent understanding of finance operations, ERP systems, and performance management.
  • Strong analytical, communication, and problem-solving skills.
  • Collaborative mindset with a passion for innovation and continuous learning.

Ideally, You’ll also have

  • Professional qualifications such as MBA, ACCA, ACA, CIMA, PMP, or Prince2.
  • Experience in proposal writing and business development.
  • A strong academic background in finance, business, or project management.

What we look for

We offer a competitive remuneration package. Our comprehensive Total Rewards package includes support for flexible working and career development, and with FlexEY you can select benefits that suit your needs, covering holidays, health and well-being, insurance, savings and a wide range of discounts, offers and promotions. Plus, we offer:

  • Support and coaching from some of the most engaging colleagues around
  • Opportunities to develop new skills and progress your career
  • The freedom and flexibility to handle your role in a way that’s right for you
  • All our employees are given a benefits package which they can tailor to suit their individual preferences. Our range of benefits include:
  • Pension
  • Maternity & Paternity leave
  • Discounted health insurance
  • Bike to work Scheme
  • Web Doctor - Free unlimited online GP consultations for you and your family
  • Recognition Awards
  • The purchase of additional annual leave
  • Cash incentives for referrals
  • Hybrid Working
  • Work Mobile
  • Free Gym membership
  • TECH MBA paid by EY
  • Travel Pass
  • Wellness rooms Available in some offices

Career Progression

  • When you join EY, you will be supported to ensure that you are enhancing your skills from day one.
  • Continuous learning, where you can develop the mindset and skills to navigate whatever comes next.
  • As you grow and develop here, you’ll discover opportunities to help customise your career journey, so that it’s as unique as you are - success is defined by you, we will provide the tools and flexibility, so you can make a meaningful impact, your way.
  • Transformative leadership, we will give you the insights, coaching and confidence to be the leader the world needs.
  • Diverse and inclusive culture, you will be embraced for who you are and empowered to use your voice to help others find theirs.
  • We have embraced Hybrid working at EY adding greater flexibility and autonomy to the roles of our employees.

Inclusion & Diversity

We recognise the strength that comes from having a diverse workforce and building a culture where we support all our people to achieve their potential. You’ll be embraced for who you are and empowered to use your voice to help others find theirs.

Show more

These jobs might be a good fit

Limitless High-tech career opportunities - Expoint
Degree in a Quality, Science or Engineering or equivalent discipline.Desired:Quality Auditing certification.Lean/Six Sigma certification.Supervisory experience. Quality Auditing certification. Lean/Six Sigma certification. Supervisory experience....
Description:




Job Summary

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

Essential Duties and Responsibilities

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required


Basic Qualifications
  • Degree in a Quality, Science or Engineering or equivalent discipline.

    Desired:

    • Quality Auditing certification.
    • Lean/Six Sigma certification.
    • Supervisory experience.
Preferred Knowledge, Skills and Abilities

• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target

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