We have a current opportunity for a Audit Manager on a permanent basis. The position will be based in Switzerland. For further information about this position please apply.
Switzerland is growing and for our Biologics organization, we are currently looking for a QA GMP Audit Manager. The QA GMP Audit Manager is responsible for the planning, hosting, execution and documentation of all customer audits and for the management of internal audits (self-inspections). The manager must be able to host inspections by regulatory authorities and related follow up. Become part of this exciting opportunity and apply now!
Key responsibilities:
* Preparing the annual internal audit plan based on risk
* Managing the audit / inspection process in TrackWise
* Execution of internal audits
* Preparing the annual internal audit report
* Leading the inspection readiness, organising preparation meetings with SMEs and identifying gaps and remediation
* Hosting customer audits and health authority inspections
* Answering queries from regulatory authorities with respect to paper inspections
Key requirements:
* Master's degree in Biotechnology, Biology, Chemistry or other natural science
* Significant auditing experience in the GMP regulated pharmaceutical industry, having an auditor certification is an asset * Understanding of the applicable cGMP regulations
* General knowledge of manufacturing processes and quality control processes
* Experience handling stakeholder on different level and function, as well as ability to establish and maintain excellent working relationships
* Fluency in English (written and spoken). German is desirable
