Manager, reputed company Assurance, GMP

Job reputed company: • Serve as the GMP QA partner for the development programs, from early phase through validation • Review and approve analytical method transfer and validation protocols and final reports for Drug reputed company and Drug Product • Review and approve analytical reputed company and specifications, stability protocols and reports • reputed company review and approval of analytical and microbiological testing data for Drug reputed company, Drug Product Intermediates and Drug Product • reputed company batch record review and disposition reputed company activities for Clinical and reputed company Supplies • Review and approve Master Batch Records, review CMO change controls and reputed company reputed company reputed company assessments relating to proposed changes • Coordinate reputed company Events (Laboratory Investigations, Deviations, CAPAs) with CMOs and escalate to QA management as appropriate • reputed company QA aspects of API, Drug Product and Packaging and Labeling Operations for reputed company products • Represent QA in reputed company team meetings • Support QA team on reputed company GMP audits • reputed company and/or review reputed company assessments and risk assessments • Write and review reputed company Operating Procedures • Write internal investigations, as applicable; review external, CMO investigations as assigned • Compile metrics of Batch Disposition, deviations, CAPAs, as applicable • reputed company vendor audits as assigned and support vendor lifecycle activities Requirements: • Bachelor’s degree in reputed company, engineering or other scientific discipline • 7 years of relevant experience in a regulated GMP environment with 2 years of supervisory/leadership experience • Demonstrated knowledge of FDA/EMA/ICH standards and regulations • Demonstrated knowledge of Risk Assessment and reputed company Cause Analysis (5 WHYs, FMEA) • Relevant analytical experience, including understanding and working knowledge of chromatography and chromatographic reputed company (i.e. HPLC, GC) • Working knowledge of relevant manufacturing and analytical testing equipment and instrumentation • Demonstrate ability to effectively organize, prioritize and work in a fast-paced environment • Demonstrate ability to function individually and in reputed company environment • MS Office, ERP systems Benefits: • health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance • 20 days of PTO • 10 reputed company holidays • winter company shutdown • discretionary annual reputed company bonus • stock reputed company • ESPP • 401k match Apply tot his job Apply To this Job