Job Description
Major tasks & responsibilities:
Review of batch documentation of branded, biologics, and APIs
Manage key quality systems including deviations, change controls, CAPAs, complaints associated with the products by liaising with CMOs, QA Manager/QP , operations, QC and other stakeholders associated with Drug Products or Medical Devices
Assess based on risk management tools and thorough and good understanding of manufacturing operations, change control, deviations and complaints
Supports technology transfers and process/ analytical method validation activities from quality operations perspective
Preparation of annual product reviews (APR/PQR) of Biologics and branded Pharma products
Manage and maintain product specification in accordance with current marketing authorizations
Act as QA stabilities coordinator
Support on review and release of clinical trial batches and ensures proper maintenance of product specification files
Responsible for overall CMO management system which guarantees tracking and follows of CMO quality notifications
Support planning and execution of internal audits.
Qualifications, Knowledge, Experience & Skills
HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
Minimum of 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
Strong knowledge of EU GMP, US CFRs.
Well versed in Microsoft Excel.
Fluent in English