Services
- Ensuring that all performance qualification (PQ) requirements are documented and successfully tested. (Including deviation management).
- Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
- Participation in the various project meetings and support the project team in all project related topics
- Project co-ordination and communication of validation issues to team members and management.
- Ensure equipment changes are implemented as per change control procedures.
- Completing work as necessary within the scope of the contract.
- Deliverables for Project:
- Performance Qualification (PQ) protocols and test scripts
- Action plan for Performance Qualification (Planning dates and resources)
- PQ report