QA Officer
On-Site , Near Llandysul Ceredigion
WORKING HOURS…
- 37.5 hours per week, Monday – Friday, 09:00-17:00.
THE ROLE…
- Coordinating and maintaining all activities required for the disposition of drug substance by Qualified Persons.
- Responsible for the compliant maintenance of the Quality Management System including review of Quality Management Systems (QMS) actions, Quality Events (QE), Corrective & Preventative Actions (CAPA), Change Controls (CC), etc.
- Responsible for the categorisation and review of QEs & CAPA plans, approval of CAPA actions.
- Responsible for the review and approval of Effectiveness checks (EC) and extension requests.
- Perform the review and approval of solution batch records (including PAS-X release).
- Review, check and approve completed batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of drug substance by Qualified Persons.
- Prepare any required corrective and preventative actions related to the release of drug substance.
- Liaise with external contractors and personnel regarding the release of drug substance.
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, 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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