Job Purpose
The Quality Specialist supports the Device and GMP Senior Quality Managers in providing Quality oversight of MoonLake’s manufacturing supply chain to ensure compliance with GMP, Device manufacturing requirements, MoonLake’s regulatory dossiers and the release schedule. Provides necessary oversight to client groups on GMP compliance within MoonLake and CDMOs, with specific emphasis on tracking and review of deviations, changes and manufacturing records. Collaborates effectively with rest of the MoonLake Quality team and consultants to ensure a seamless delivery of support to MoonLake functional groups.
Key Accountabilities
Key Accountabilities
- Become familiar with MoonLake products, technical agreements, regulatory dossiers and subcontracted manufacturing supply chain.
- Maintain awareness of international GMP compliance requirements relevant to MoonLake’s Drug-Product-Device combination products.
- Become familiar with MoonLake’s quality systems (contributing to their maintenance and ongoing improvement).
- With the Senior Manager GMP Quality, ensure GXP compliance of contractors for Drug Product manufacture and testing, delegating as the QA contact with CMO/CTO on set-up, deviations and change assessment and batch review.
- With the Senior Manager Device Quality, ensure compliance of contractors for manufacture and testing of DP-device combination products, delegating as the QA contact with CMO/CTO on set-up, deviations and change assessment and batch review.
- Become familiar with MoonLake’s packed stock oversight and release procedures and ensure QPs are made aware of any compliance issues which could impact upon the safety of MoonLake's clinical products.
- Manage MoonLake’s internal review process for any deviations and changes associated with DP or device manufacture.
- Undertake other quality assurance duties as required.