QA Officer | Ceredigion
To support the effective functioning of the Quality Management System and provide assistance to the QA Department as required.
- Organising all activities required for the disposition of finished product by QP’s
- Responsible for the compliant maintenance of the QMS including review of QMS actions, QE’s, CAPA, CC’s etc.
- Review, check and approve finished batch and ancillary quality documentation to ensure compliance with GXP and assist the disposition of finished product by Qualified Persons.
- Generate Certificates of Analysis and statements of GMP Compliance.
- QA review of Validation documentation
- Participation in inspection readiness activities and the internal audit program
- To support the release, shipment, quarantine, and rejection procedures for drug substance and finished product.
- To help the release, shipment, quarantine, and rejection procedures for drug substance within and finished product.
- Support the product recall procedure.
- Support release of cleaning, solution, bulk immunogens and Drug Substance within production timelines.
- To ensure KPI’s are prepared and trended for the monthly report, management review and annual product reviews.
WHAT YOU WILL NEED…
- Educated to degree level or equivalent in applicable scientific discipline such as Chemistry, Biochemistry, Microbiology or life sciences (An applicable level of related industry experience in lieu of a degree will be considered)
- Prior experience of working within the pharmaceutical industry, preferably with experience in GMP and Quality Assurance roles
- Computer literacy (including word, power point, excel, databases)
- Experience of working with a regulated industry
- Drive & access to own car (due to the location)
- Join a friendly, supportive team
- Company bonus scheme
- Permanent Health Insurance
- Excellent Pension & holiday allowance