QA Officer
On-Site , Near Llandysul Ceredigion
WORKING HOURS…
- 37.5 hours per week, Monday – Friday, 09:00-17:00.
THE ROLE…
- Coordinate and manage all necessary activities to support the disposition of drug substance by Qualified Persons.
- Maintain the Quality Management System by overseeing Quality Events, CAPAs, and Change Controls to ensure total compliance.
- Categorize and review Quality Events while approving CAPA plans and individual actions.
- Review and approve effectiveness checks and any necessary extension requests.
- Manage the review and approval of solution batch records, including PAS-X release.
- Verify all batch and ancillary quality documentation to ensure it meets GXP standards for drug substance disposition.
- Develop and implement corrective and preventive actions specifically related to the release of drug substance.
- Act as a key liaison between external contractors and internal personnel regarding product release.
WHAT YOU WILL NEED…
- Degree (or equivalent experience) in a scientific field such as Chemistry, Biochemistry, Microbiology, or Life Sciences.
- Experience in the pharmaceutical industry is desirable, ideally in GMP and Quality Assurance roles.
- Proficient with computers, including Word, PowerPoint, Excel, and databases.
- Experience working in a regulated industry.
BENEFITS…
- Excellent holiday package
- Private Medical Insurance
- Fantastic location (near countryside and coast)
BIOTECH
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