- Bubendorf, Basel-Landschaft, Switzerland
- On-site
- Full-time · Manager
Provide independent technical and GMP oversight for activities covered by the Swiss establishment licence, combining regulatory accountability and sound quality judgement.
Responsibilities
- Act as the designated RP/FvP for the assigned activities under Bachem’s Swiss establishment licence and ensure effective technical supervision
- Provide independent oversight of applicable manufacturing, testing, batch disposition, storage and distribution activities in accordance with Swiss GMP/GDP requirements and Bachem’s Pharmaceutical Quality System
- Make or support independent quality and regulatory decisions for significant deviations, investigations, CAPAs, changes, product-quality defects and other critical quality events
- Ensure appropriate escalation and measures where product quality, patient safety or regulatory compliance may be affected, including quarantine, supply restrictions, withdrawal or recall where required
- Support inspections, establishment-licence activities and required communication with stakeholder and other health authorities
Requirements
- University degree in pharmacy, chemistry or another relevant scientific discipline