The QA Validation Specialist is responsible for ensuring the compliance of our three sites in Germany, including its state-of-the-art storage and environmental monitoring systems. He or she serves has frequent contact with our customers in client audits as well as internal stakeholders on site.
What will you do?
- Responsible of follow-up the inventory list of Equipment, Cold & Ambient Storage Rooms and ensure devices are maintained in a validated state.
- Review and approval of validation documents (URS/ DQ/ RA/ IQ/ OQ/ PQ and Summary Report)
- Review and approval of Re-Assessment/ Periodic Reviews (Equipment/ Cold & Ambient Storage Rooms)
- Support, Initial quality review and approver during investigation/deviation/ CAPA
- Gap analysis on current GMP requirements
- Perform Risk Analysis according to SOP/ internal Requirements
- Generation of re-qualification plans
- Generation of corresponding qualification / validation documents
- Creation, revision and updating of SOPs
- Participation in client and regulatory audits and inspections