Allergan plc (NYSE: AGN) is a bold, globalpharmaceutical company and a leader in a new industry model - GrowthPharma. Allergan is focused on developing, manufacturing andcommercializing branded pharmaceutical, device, biologic, surgical andregenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products forthe central nervous system, eye care, medical aesthetics and dermatology,gastroenterology, women's health, urology and anti-infective therapeuticcategories. With commercial operations in approximately 100 countries, Allerganis committed to working with physicians, healthcare providers and patients todeliver innovative and meaningful treatments that help people around the worldlive longer, healthier lives every day.
Allergan is a company that will inspire youto aim high with your ambition. Where you can build bridges all over the world.Where you can power ideas that drive change. And where you will act fast anddrive results for customers and patients. Power your future & joinour bold team.
The Quality Analyst III will be to fostercompliance and continuous quality improvement to meet customer expectations ina highly regulated environment. Theprimary responsibility of this role is to lead, ensure technical consistency,and ensure compliance of Allergan's CAPA and Non-conformance Quality System.
Main Areas of Responsibilities
Non-conformances: Review non-conformances and,if required, initiate CAPAs. Partnerwith authors or others to ensure records are factually written and accuratelyportray the event. Verify that the eventis properly trended, evaluated, and assessed to ensure appropriate actions aretaken. Ensure that NCR records meet all compliance requirements.
Corrective Actions/Preventive Actions (CAPA):Ensure that investigations are thorough, factually written and focused on rootcause determination. Provideguidance/training to all personnel performing investigations. Ensure thatcorrective actions are appropriate for the elimination of root cause andprevent reoccurrence. Proactivelywork/motivate and guide facility teams to ensure corrective action effortsaddress root cause and results are effective. Ensure that all actions are verified and/or validated and do notadversely impact finished devices. Ensure that CAPA records meet all compliance requirements.
NCR/CAPA System Metrics: Assist in the NCR/CAPAsystem data collection, interpretation and documentation to support all systemmetrics (monthly, quarterly, and ad hoc report needs) on a timely basis.
Effectiveness Checks (EC): Assist in thedevelopment of effectiveness check plans and ensure that all effectivenesschecks are appropriate at assessing the effectiveness of closed CAPAs. Confirm that effectiveness checks utilizestatistically-sound sampling plans and results are adequately assessed todetermine pass/fail status.
Participate in regulatory audits / inspectionsas required, including audit front room and back room support.
Electronic CAPA system (TrackWise ): Provideguidance/training to all personnel performing activities within the electronicCAPA system (TrackWise ).
*LI-DM1 Preferred Skills/Qualifications
Certified Quality Engineer (CQE) preferred
Ability to train and motivate in area of complianceand quality improvement.
Excellent oral and technical writing skills withthe ability to interface effectively and professionally at all levels.
Minimum2-4 years of Quality Assurance/Quality Engineering/Engineering/Operationsexperience
Experiencein leading investigations and CAPA activities.
Experiencein quality improvement processes, quality systems and tools.
Knowledgeof regulatory agency requirements.
Bachelor'sdegree in Engineering or Science related discipline is required.