Key role requirements:
- Maintenance of all Site QMS systems, performing periodic reviews of the above systems and reporting these at management review.
- Assist departments with investigations and drafting Deviation/complaint/Change Control as required.
- Maintain documentation control processes and issuing for all QMS systems.
- Complete Supplier complaint reports and monitor close out response from suppliers.
- Maintain Customer complaints files, complete investigations, and ensure complaints reported to appropriate MAH.
- Review of Bimeda and third-party Product release documentation, complete BUK Warehouse product/batch release and maintain QAD inventory status.
- Maintenance of Finished product Retains and the retain room including annual inspections.
- Complete incoming inspection and FMD verification checks for receipt of Brancaster Pharma product. Complete QA review documentation for QP batch release.
- Responsible for the preparation of QA department SOPs Assist in preparation of production and warehouse department SOP’s as required.
- Deliver training on QA SOPs to production/warehouse employees. Provide QA relevant SOP and GMP/GDP training for induction/new starters.
- Perform Internal/external audits as required within the group and ensure the provision of well documented audit results and action plans as required.
- Management of key GxP suppliers, including supplier approvals and periodic reviews.
- Responsible for incoming QC inspection of all packaging components and materials and complete inventory release.
- Coordinate and oversee contracted QC activities with external laboratories.
- QA Batch review and approval of Colief production dispensing / packing records and Face Mask Manufacturing Records.
- Generation of Validation protocols and reports, support departments in execution of protocols.
- Review of QC product testing reports, generation of batch Certificate of Conformity (CoC) and inventory release.
- Support the Plant/QA Manager in the compilation of regulatory submission files and regulatory audits.
Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.
- Experience of working with in a regulated environment, GMP/GDP or Food Manufacture
- Strong analytical/quantitative skills
- Good computer skills with high proficiency in Microsoft Office a plus
- Thorough understanding of quality systems and cGMPs.
- Self-initiating / self-directed
- Problem solving ability using robust tools
- Thoughtful individual who understands the value of coaching and supporting their team to exceed expectations
- BSc Degree in Quality Assurance or other related discipline
- 1+ years’ experience within a pharmaceutical Quality Assurance role
- Internal/External Auditor qualification
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.