:
1. Offer quality assurance supervision for operational tasks within the designated team.
2. Review sterilization cycles, FMS systems, and other key controls of clean rooms.
3. Manage logbooks and support area controls.
4. Perform online review of batch records.
5. Close batch records with associates LIMS & SAP transactions and C of A generation.
6. Review and update Standard Operating Procedures and Controlled Documents.
7. 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.
8. Direct the packaging departments; uphold conduct standards and adherence to SOPs.
9. Actively produce and promptly assess minor DRs & CAPA with cell members.
10. Produce and promptly evaluate/implement level 0 & level 1 modification controls with cell members.
11. Conduct local area and local system audits.
12. Train and mentor Operations staff and QA peers.
13. Communicate effectively, attend Tier 1 meetings, and participate in planning and problem-solving activities.
14. Offer re-validation resources to the aligned cell effectively.
15. Observe, incubate, read, and write reports for media fills.
16. Conduct clean room physical checks – velocities, air patterns, DOP tests, and particle counting.
17. Perform autoclave load pattern re-qualification.
18. Test sterilizing filters.
19. Validate cleaning processes.
20. Conduct AQL-based Visual Inspection.
Experience / Qualifications:
21. Preferred relevant science-based degree, such as Microbiology, Chemistry, Biology, or Pharmacy.
22. Proven experience in the pharmaceutical industry, preferably in sterile product manufacture.
23. In-depth knowledge and understanding of cGMP and other regulatory guidelines for pharmaceutical manufacturing.
24. Excellent interpersonal skills with the ability to challenge behaviors at all levels of the organization.
25. Proactive approach to continuous improvement and project work.
Our package includes a variety of adaptable benefits like Pension and Healthcare, along with competitive pay. Join our enthusiastic team working towards making a tangible difference in the world!