QA GMP Manager

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.
Depending on the consultant’s experience, the focus will be on Clinical Trial Material manufacturing and release or commercial packaging site implementation.
Responsibilities

• QA oversight of external manufacturing and packaging partners
• Review and approval of manufacturing documentation
• CTM / IMP packaging and batch release activities
• Commercial packaging site implementation
• Packaging process and transport validation
• QTA negotiation and updates
• eQMS documentation and process support
• SOP creation and review
• Represent QA in internal and external meetings

Requirements

• Strong QA GMP experience within pharma/biotech
• Experience with CTM / IMP manufacturing, packaging and release and/or commercial packaging
• Experience working with CDMOs or external manufacturing partners
• Good knowledge of GMP and quality systems
• Packaging/transport validation experience is an advantage
• Able to work independently in a small, fast-paced environment