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Title: Senior Specialist, Quality SystemsRequisition ID: 66434
Date: Jul 30, 2024
Location: Waterford, Munster, IE
Department: Quality
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: Management of customer complaintsLead and perform risk assessments and implement control plans.Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA'sSupport quality systems implementations and relevant trainingLead in Continuous Improvement of Quality processesInteract and collaborate with Operations and other functions and West sites to support production and timely resolution of issues and investigations.Host AuditsComplete supplier assessmentsEnsure compliance with customer agreements and specificationsPerform Document Controller tasks as requiredMonthly and quarterly reporting of Quality KPIsParticipate in internal audit and Shop Floor audit programMaintenance 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.Other duties as assigned.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 validationAnalytical Method, Equipment/Process and Software QualificationInvolvement in new product introduction or technical transfer activities.Competencies: 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.Travel Requirements: Must be able to travel up to 10% of the time.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.
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