Quality Officer Pharma | Quality Officer Pharma (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role involves ensuring regulatory compliance and adherence to international cGMP and internal regulations within a biopharma drug product unit. The Quality Officer will be responsible for reviewing and approving change requests and documents, contributing to the improvement of the internal Quality Management System, and defining standardized procedures. They will act as a key contact for quality-related inquiries within the change control process, particularly concerning sterile manufacturing, packaging, and quality control of biopharmaceuticals. The ideal candidate will possess a degree in pharmacy, biopharmacy, biology, or chemistry, coupled with extensive professional experience in biopharmaceutical manufacturing and GMP compliance. This position offers a challenging opportunity within an innovative pharmaceutical company, providing comprehensive onboarding and potential for professional development.
Required Skills
Education
Bachelor's or Master's degree in Pharmacy, Biopharmacy, Biology, or Chemistry, or comparable qualification
Experience
- Several years of professional experience in pharmacy, biopharmacy, biology, or chemistry
- Extended knowledge of biopharmaceutical manufacturing, especially regarding compliance and quality-relevant topics in process and quality control
- Several years of experience regarding GMP Compliance and quality topics
- Good knowledge of regulatory requirements
Languages
Additional
- The position is initially limited to 18 months, with an option for extension.
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