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Job Description
Job Summary: We are seeking a highly motivated and detail-oriented Qualified Person to join our quality assurance team and ensure the highest standards of product quality and compliance. The Qualified Person will implement and execute batch approval and regulatory authorization for the site, collaborating with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams.
Responsibilities:
- Provide quality leadership, direction, training, and governance for the specific area of responsibility.
- Monitor GMP compliance and verification of effective implementation of key GMP programs and systems.
- Approve quality-related documents and review change controls, deviations, failure investigations, and other GMP documents.
- Issue QP declarations, understand regulatory requirements, and contribute to regulatory documents.
- Ensure manufactured biotech drug substance batches are certified in accordance with all required regulations.
Requirements:
- BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline.
- Approved by member state as a licensed QP in order to be named on the company licence as a QP.
- Minimum of 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
- Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.