Senior Specialist, Quality Engineer
Location: Waterford, Munster, IE
Job Summary
To ensure quality and technical standards are in place and in use, ensuring product and service consistently meet 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
* 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 CAPAs.
* 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.
* Desired: Lean/Six Sigma certification.
* Desired: Supervisory experience.
Preferred Knowledge, Skills and Abilities
* 5+ years’ previous industrial experience 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.
Travel Requirements
10%: Up to 26 business days per year.
Equal Employment Opportunity
West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies is contingent upon the satisfactory completion of post‑offer background screening and/or drug screening. #LI-AS1
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