QA officer
- Swindon
- Permanent
- Full-time
- Offer quality assurance supervision for operational tasks within the designated team.
- Review sterilization cycles, FMS systems, and other key controls of clean rooms.
- Manage logbooks and support area controls.
- Perform online review of batch records.
- Close batch records with associates LIMS & SAP transactions and C of A generation.
- Review and update Standard Operating Procedures and Controlled Documents.
- Direct clean rooms and support zones; ensure behavior and conformity to SOPs, including entering clean rooms physically and keeping up with at least an L1 license.
- Direct the packaging departments; uphold conduct standards and adherence to SOPs.
- Actively produce and promptly assess minor DRs & CAPA with cell members.
- Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members.
- Conduct local area and local system audits.
- Train and mentor Operations staff and QA peers.
- Communicate effectively, attend Tier 1 meetings, and participate in planning and problem-solving activities.
- Offer re-validation resources to the aligned cell effectively.
- Observe, incubate, read, and write reports for media fills.
- Conduct clean room physical checks – velocities, air patterns, DOP tests, and particle counting.
- Perform autoclave load pattern re-qualification.
- Test sterilizing filters.
- Validate cleaning processes.
- Conduct AQL-based Visual Inspection.
- Preferred relevant science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy.
- Proven experience in the pharmaceutical industry, preferably in sterile product manufacture.
- In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing.
- Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization.
- Proactive approach to continuous improvement and project work.