Senior Quality Engineer, Compliance
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Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. Allergan is a company that will inspire you to 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 and drive results for customers and patients. Power your future & join our bold team. Position Description This position performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation at the Waco facility. Main Areas of Responsibilities
Providing Quality Assurance oversight and assessment of operational activities in Production, Compliance, Validations, and Technical Services projects.
Providing guidance and executing internal and external audits to ensuring processes and equipment validations meet regulatory standards and are cGMP compliant.
Serves as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories, IS, Manufacturing, and Engineering.
Reviewing and approving equipment validation documentation (e.g., protocols, deviations, and final reports).
Supporting change control activities associated with processes and equipment validations.
Managing and coordinating QA support for new and existing process equipment validation implementations.
Providing CSV oversight based on the education and training of the individual.
Proved support in defining statistical design and analysis for process-development, technology transfer, analytical development, process validation and re-qualifications, manufacturing, chemistry and microbiology laboratories, incoming QA, investigations, CAPAs, compliance, complaints process.
Statistical lead for APR process, Continued Process Verification (CPV) program, trend analysis, establishment of monitoring limits, evaluation of stability data
Metrics gathering, analysis, and reporting
Act as a resource regarding statistical issues including experimental design, sample size, statistical analysis and interpretation of results
Benchmarking industry best practice and Regulatory expectations related to statistical practices and expectations
Perform other duties as assigned.
Minimum of ten (10) years of experience with a minimum of five (5) years working in relevant areas such as process validations or technology transfer.
A Master’s degree may substitute for one year experience.
Strong user of Excel.
Strong experience in Statistical programs such as Minitab..
Experience in a GMP regulated environment preferred.
Demonstrated ability to apply analytical methods
Demonstrated ability to work with all levels of Management.
Experiences in Six Sigma Black Belt methodology and/or KTA problem solving preferred
Demonstrated business acumen
Detail-oriented and self-motivated
Preferred Requirements: Education
Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution.
Graduate degree is preferred.
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