דרושים Specialist Customer Service Operations ב-West Pharma ב-Ireland, Dublin

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

• 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.

• 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

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).

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

• 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

• 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

Senior Compliance Specialist is responsible for leading the coordination of Change Control activities and ensuring compliance with internal and external Change control requirements. The role will serve as the subject matter expert and administrator for change control documentation.

• Oversee overall global Change Control process; leading change control review board activities (documentation, data, customer notifications and approvals, etc.)
• Collaborate with cross functional teams on West change controls and provide guidance and Quality consultation to change control owners on change levels and associated tasks.
• Assist change owners to outline action plans, tasks and responsibilities to ensure execution of changes occur in a timely manner
• Drives visibility and oversight to changes across network to ensure applicability and consistency.
• Oversees assessment of change controls and assures change Impact is considered across products, platforms, life cycle phases, supply chain, and processes (i.e. combination products).
• Ensure change control information is accurately entered into the appropriate tracking database
• Provide mentoring and training to change owners on change control processes and tools
• Work with global, cross-functional groups, manufacturing sites, and customers as needed to determine compliance with customer specifications.
• Monitor and communicate metrics and trend reports to management for the Change Control system as needed
• Collaborate on cross functional teams in determining specification content.
• Perform evaluation of change control processes and tools to drive continuous improvement activities.

• Ensure adherence to corporate Quality System requirements

• Bachelor's Degree in Science or equivalent experience required and
• Master's Degree in Science or equivalent experience preferred

• Minimum 5 years of experience in regulated Quality Assurance / Quality Control required and
• Experience with qualifications, Quality Risk Management, quality systems such as ISO 13485, 21 CFR 820, ISO 14971, Medical Device Product Development Life Cycle Activities, Verification / Validation Activities, Risk Management, DHF Activities, MasterControl, SAP, Share Point, Teamcenter preferred

• Ability to work independently, multi-task and thrive in fast-paced environment
• Excellent critical reading and writing skills
• Must have effective problem solving and interpersonal skills
• Ability to work independently, multi-task and thrive in fast-paced environment
• Problem solving including root cause failure analysis methods
• Planning/organizational skills
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to comply with the company’s safety policy at all times
• Knowledge of cGMP, cGDP

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• 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
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual