Descripción
Quality GMP Consultant
Location: Remote within Switzerland
Workload: 100%
Contract length: 6 months
Start date: ASAP
We are supporting a late-stage biotech looking for an experienced QA GMP Consultant to provide additional support across clinical and commercial manufacturing activities.
The role will be split across two key areas: Clinical Trial Material manufacturing & release and commercial packaging site implementation.
Responsibilities
Clinical Trial Material Manufacturing & Release
- Review and approval of manufacturing documentation, pre- and post-manufacturing
- Clinical packaging site oversight
- CTM batch release
- QTA negotiation and updates
- eQMS documentation administration
- Process execution and improvement support
- Represent QA in internal and external meetings as SPOC
- SOP creation and review
Commercial Packaging Site Implementation
- Review and approval of manufacturing documentation, pre- and post-manufacturing
- Commercial packaging site oversight
- QTA negotiation
- Packaging process validation
- Transport validation
- eQMS documentation administration
- Process execution and improvement support
- Represent QA in internal and external meetings as SPOC
- SOP creation and review