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Audit and CAPA Lead
- Posted 16 July 2023
- LocationSwitzerland
- Job type Permanent
- Reference89229
- Contact NameDuncan Johnston
Job description
Senior GCP Manager - Audit & CAPA Lead - Switzerland
BioTalent is supporting a global biopharmaceutical organisation in the key hire of the Audit & CAPA Lead. You will play a crucial role in ensuring the effectiveness of our audit and corrective and preventive action (CAPA) processes whilst managing the master audit plan. Reporting to the Head of Quality, your responsibilities will include:
- Overseeing the Audit & CAPA system, acting as the main point of contact for system-related inquiries.
- Developing global GxP audit programs and managing outsourced audits.
- Leading all aspects of the audit process from planning to report delivery.
- Assisting in Regulatory Authority Inspections.
- Collaborating with the GxP Quality Lead for timely CAPA development.
- Generating meaningful metrics to drive continuous improvement.
Requirements:
- University degree in Pharmacy, Science, or related field.
- Extensive quality assurance management experience in pharmaceutical or biotech industries.
- Strong experience with GxP Audits and tracking systems (CAPAs, deviations).
- Proficient in validated electronic quality systems tools (e.g., TrackWise, Veeva).
Join our team and contribute to our mission of advancing healthcare. All applications will be treated with utmost confidentiality.