Job Description
Job Description
Location: Bulle, Switzerland
Activity rate: 100%
Type of contract: Temporary contract (until with a potential extension)
Start Date: ASAP
Key Responsibilities
- Coordinate the transfer, validation, and verification of physicochemical methods (HPLC, GC, UV, KF, dissolution) in compliance with cGMP and regulatory standards.
- Draft and review all lifecycle documentation, including validation plans, protocols, risk assessments, and final reports.
- Act as the technical SME for investigations, Change Controls, and continuous improvement projects.
- Lead the global transfer strategy and manage post-transfer activities until the full commissioning of methods in the QC laboratory.
- Present and defend analytical validation and transfer documentation during health authority inspections and partner audits.
- Transfer technical knowledge to QC teams through dedicated coaching a...