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