Quality Specialist Complaints jobs at West Pharma in Ireland, Dublin
West Pharma Senior Specialist Supplier Quality Ireland, Dublin
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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.
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 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
Bachelor’s degree in engineering or related science
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
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.
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West Pharma Specialist Customer Service Operations Ireland, Dublin
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- Fostering high performance culture, focused on efficiency, accountability, collaboration, and continuous improvement
- Supporting all inflowing requests for customer related documents globally
- Managing orders accurately End to End for standard orders, samples, lab orders for proprietary business and contract manufacturing in the relevant ERP system
- Issuing Quotations, Order acknowledgements, Returns, Credit and Debit notes; DA‘s, notifications
- Verifying orders which come in through the OCR queue or webstore
- Taking care of Export and Import handling as well as pricing related activities,
- Initiating new customers through data creation, triggering Item creation
- Updating customer master data and information records through SAP as well as providing copies of certifications, documents etc. for customers.
- Handling Document Control, CMIR incl. Shipping instructions
- Internal stakeholder relationship management (SCM/Ops/Quality/Shared Services)
- Liaising with plants and wider supply chain to identify best way forward in case the customer requested dates cannot be met
- Cooperation with the customer experience unit supporting internal audit findings and projects for continuous improvement
- Other duties as assigned
- High School Diploma GED or equivalent required
- Minimum 3 years in client services or customer service required
- Knowledge or experience with ERP tools like SAP with Sales and Distribution
- Working knowledge of MS Office or the willingness to learn it quickly
- Highly proficient in written and spoken English and one further language of our business areas
- Strong communication skills
- Strong people skills – approachable, good listener, empathetic
- Strong learning capacity
- Ability to work independently in global environment
- Understanding of Incoterms and Export/Commercial Documentation Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Able to comply with the company’s safety and quality policies at all times
- Communication, quick decision making, interpreting data, reading or writing, must be able to express or exchange ideas with team members
- Must be able to understand direction and adhere to established procedures
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West Pharma Senior Specialist Regulatory Affairs Ireland, Dublin
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The Regulatory Affairs Sr. Specialist is responsible for post market activities for medical devices, supporting department regulatory processes and procedures, supporting strategies, authoring, reviewing, and supporting global registrations. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.
- Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations and industry standards.
- Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF and vigilance reports and field safety corrective actions to Notified Bodies, EMA, and other global competent authorities.
- Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in West’s portfolio.
- Support West’s medical device EU importation requirements as Importer in accordance with Article 13 of MDR.
- Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose.
- Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken.
- Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
- Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals.
- Adhere to all applicable government requirements and West practices, and procedures to maintain compliance.
- Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.
- Bachelor's Degree in science, math, engineering, or related discipline required or
- Master's Degree in science, math, engineering, or related discipline preferred or
- PhD in science, math, engineering, or related discipline preferred
- Experience: Bachelors with +5 years or master’s degree/PhD with 3+ years of medical device regulatory experience
- Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485 and US FDA regulations (Title 21CFR820), ISO 14971, and ISO 14155, EU combination product regulations (e.g., EMA/CHMP/QWP/BWP/259165/2019)
- Experience in preparation of dossiers for submission to competent authorities including supporting design and development of medical devices and combination products over the product lifecycle
- Strong decision-making, communication, and technical writing skills
- Ability to work independently and manage multiple priorities and ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement in a changing environment
- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
- Established scientific and quality expertise with criteria described above
- Experience in direct engagement with regulatory authorities
- Regulatory compliance competency in Quality Management Systems
- Knowledge of US FDA regulations and submission pathways (e.g., 510(k), DMF, MAF, BLA)
- Familiarity with US drug-device and ROW combination product requirements
- Advanced degree and/or RAC certification
- Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time.
- Ability to comprehend principles of math, science, engineering, and medical device use. Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions.
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally.
- Ability to work in a fast-paced environment.
- Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
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West Pharma Quality Technician - Shift Role FTC Ireland, Dublin
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Job Summary:
In this role, you will perform a variety of tasks and conducts test procedures in regard to the quality process, ensuring that the pre-determined high standards of quality are achieved and maintained. Reporting directly to the Senior Quality Engineer.
Essential Duties and Responsibilities:
- Review and approval of metrology reports, where appropriate, for batch release and validation purposes
- New product validation, analysis and reporting.
- Quality support to Engineering and Production Departments.
- Establish and maintain documentation in line with West Dublin and West Pharmaceutical Services Quality Systems.
- Liaise with customers and suppliers on new and existing projects.
- Receiving and inspection of incoming goods and materials
- Ensure that all parts/ materials, which require incoming inspection, conform to all requirements and applicable drawings and specifications.
- Maintain good communications both internally and externally.
- Ensures that all metrology equipment is correctly calibrated.
- Assists shift personnel with quality issues and/or measurement techniques.
- Assists in problem resolution with customers.
- Makes periodic audits as requested and completes necessary documentation.
- Archives quality records, samples and log procedures.
- Makes periodic clean-out of records and samples exceeding minimum retention requirements as per West procedures.
- Batch paperwork review and final decision to release product for shipment
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Perform additional duties at the request of the direct supervisor.
- Other duties as assigned.
Basic Qualifications:
- Must possess good communication/interpersonal skills; must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.
- Must understand the principles of Batch Control and FIFO.
- Must be able to hold a high degree of confidentiality.
- Must have knowledge of EU-GMP
- Computer literacy required.
Preferred Knowledge, Skills and Abilities:
- Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have relevant industrial experience in a high volume injection-moulding environment.
- Basic knowledge of statistical sampling of product
- Understanding of injection moulding processes.
- Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred.
Travel Requirements:
Physical and Mental Requirements:
- Physical Requirements: must be able to be exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
- Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.
Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates
- Quality Engineer
- Senior Quality Engineer
- Quality Engineering Manager
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West Pharma Specialist Trade Compliance Ireland, Dublin
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This position will be responsible to coordinate, execute and maintain trade related programs for West EU locations. The focus will be on executing and maintaining compliance for West products, procurement and sales activities for EU cross-border transactions. The role is responsible to ensure West transactions are compliant with EU national, regional and local import and export laws and requirements and to ensure efficient and consistent cross border transactions.
- Responsible for ensuring West EU import and export declarations adhere to applicable SOP’s to minimize compliance exposure and to optimize costs
- Executes cross border activities according to the EU trade compliance manuals and procedures
- Works with West sites, 3rd party service providers, and customs broker(s) to resolve issues and questions that arise regarding day-to-day customs entries and export declarations
- Provides trade compliance related codes such as HS, export control codes, Partner Government Agency codes, and other compliance related master data for EU imported and exported products
- Maintain and, as necessary, retrieves required records relating to import and export affairs.
- Prepares, submits and maintains special compliance related documentation to support import/export declarations
- Provides transactional support for duty optimization programs such as Free Trade Agreements
- Conducts post-entry audits---Coordinate any Post Entry Corrections, where necessary, with West-designated Customs Broker.
- Reviews and manages documentation required for import/export declarations, use of Free Trade Agreements, Preferential Duty Programs and Duty Drawback Programs
- Participates in and supports operational projects involving or impacting Trade Compliance at West EU facilities (e.g. systems implementations, new business models, etc.)
- Participates in cost-saving and process improvement initiatives for Trade Compliance activities
- Other duties as assigned
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Must be able to maintain confidentiality and resolve conflicts
- Ability to make independent and sound judgments
- Read and interpret data, information, and documents
- Analyze and solve problems
- High School Diploma required
- Bachelor's Degree Business or relevant field preferred
- Minimum 3 years related experience required
- Working knowledge of EU import/export regulations and TARIC
- AEO certification/program knowledge
- 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
- Able to comply with the company’s safety policy always
- Able to comply with the company’s quality policy always.
- Strong analytical ability
- Solid communication skills
- Ability to speak English
- Ability to work with and within global cross-functional teams
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West Pharma Specialist Accounts Payable Ireland, Dublin
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- Build business relationship with Vendors in an assigned portfolio. This includes:
- Working directly with Purchasing and Receiving dept's to resolve invoice issues
- Correspondence with vendors and managing inquiries
- Maintain records of vendor contacts and ongoing vendor issues
- Preparation of payments to Vendors as per the agreed payment schedule
- Matching, coding and processing of Vendors Invoices and Credit Notes
- Ensure invoice on hold targets are met
- Work with all internal departments to attain proper approval for invoices
- Reconciliation of vendors’ statements, as required
- Produce monthly reports
- Monthly close responsibilities
- Bachelor's Degree or equivalent experience required
- Minimum 3 years Previous Shared Service Centre experience with multinational publicly quoted company experience required
- 2+ years of experience in payables required
- Experience of SAP or other major ERP systems preferred
- Knowledge and understanding of basic accounting principles.
- Proficient in MS Office applications
- Team player, positive and flexible attitude
- Excellent communication skills i.e. ability to communicate and work effectively with a wide range of stakeholders
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times
- Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
- Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
- Position operates in a professional office environment. May stand or sit for extended periods of time
- Read and interpret data, information and documents
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze and solve problems
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West Pharma Specialist Accounts Payable Ireland, Dublin
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- Build business relationship with Vendors in an assigned portfolio. This includes:
- Working directly with Purchasing and Receiving dept's to resolve invoice issues
- Correspondence with vendors and managing inquiries
- Maintain records of vendor contacts and ongoing vendor issues
- Preparation of payments to Vendors as per the agreed payment schedule
- Matching, coding and processing of Vendors Invoices and Credit Notes
- Ensure invoice on hold targets are met
- Work with all internal departments to attain proper approval for invoices
- Reconciliation of vendors’ statements, as required
- Produce monthly reports
- Monthly close responsibilities
- Bachelor's Degree or equivalent experience required
- Minimum 3 years Previous Shared Service Centre experience with multinational publicly quoted company experience required
- 2+ years of experience in payables required
- Experience of SAP or other major ERP systems preferred
- Knowledge and understanding of basic accounting principles.
- Proficient in MS Office applications
- Team player, positive and flexible attitude
- Excellent communication skills i.e. ability to communicate and work effectively with a wide range of stakeholders
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times
- Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
- Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
- Position operates in a professional office environment. May stand or sit for extended periods of time
- Read and interpret data, information and documents
- Must maintain the ability to work well with others in a variety of situations
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze and solve problems
These jobs might be a good fit
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.
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 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
Bachelor’s degree in engineering or related science
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
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.
These jobs might be a good fit
