Jobdescription
We are looking for a QA Batch record reviewer for our client Lonza AG in Visp.
responsibilities:
- Executed Batch record review
- Represents QA in project/tech transfer organizations for new biotech manufacturing processes.
- Responsible for review and final release of records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, CAPAs, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
- Authoring/approval of SOPs
- Participates and supports regulatory inspections and customer audits
- Actively supports the Quality culture as a role model
- Strong background in cGMPs
- experience in representing Quality and Compliance in projects
- Good communication skills and experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- Excellent written and spoken English.
- Knowledge of written and spoken German would be an advantage
