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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