Key responsibilities of the Senior QA Officer include:
- Review of batch documentation of branded, biologics, and APIs as preparation of batch release by the QP
- Manage key quality systems including deviations, change controls, CAPAs, complaints associated with the products by liaising with relevant stakeholders
- 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 when required.
- Preparation of annual product reviews (APR/PQR) of Biologics and branded Pharma products
- Manage and maintain product specifications in accordance with current marketing authorizations
- Act as QA stabilities coordinator for ensuring continuous assessments of trends and preparation of stability reports
- Support on review and release of clinical trial batches
- Support the maintenance and update of QA B&CM quality management system
Key requirements of the Senior QA Officer include:
- HBO or Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education
- Strong knowledge of EU GMP, US CFRs.
- Fluent English
- Minimum of 3 years of relevant experience in GMP manufacturing operations with experience in sterile manufacturing
- Minimum of 1 year experience in QA operations of biological Drug Substance and/or Drug Product manufacturing.
