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Senior QA Specialist – Biologics
An exciting opportunity has become available working as a Senior QA Specialist with a global
Biotech based in the Nordics. The ideal candidate will have a GMP and a Biologics background.
- Working as a QA contact person with API as an area of responsibility.
- Provide general QA expertise and support for API
- Provide QA expertise during the investigations of Deviations or OOS; and QA approve these and their related CAPAs.
- Support and approve Change Control records
- Contribute to the preparation of inspections as per defined and agreed role.
- Participate in CAPAs resolution of inspection findings.
- QA review and approval of product specifications and master batch records.
- Review of batch records and associated documents from API before a formal release to the next manufacturing step
- QA review and approval of records and reports related to area of responsibility.
- Draft, review and approval of Quality Operations SOPs and of documents from areas of responsibility
- QA review and release of Cell Banks
- QA approver for any quality records related to API processes