Suitable candidates will need to possess skills/experience in the following areas: -
- 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
- Participate in CAPAs resolution of inspection findings.
- QA review and approval of product specifications, master batch records and other quality records related to the API process.
- Review of batch records and associated documents from API before a formal release to the next manufacturing step
- Draft, review and approval of Quality Operations SOPs and of documents from areas of responsibility
- QA review and release of Cell Banks