1. Demonstrate strong leadership and management skills, communicate effectively, manage multiple workloads and coordinate all QC activities in the microbiology laboratory with the QC Manager.
2. Participate in the development and installation of a KPI system in the microbiology laboratory assisting the QC Manager
3. Manage and schedule routine and annual maintenance, troubleshooting and of all analytical equipment and analytical practices and procedures in order to uphold continuous improvement in the microbiology laboratory.
4. Manage Analyst work schedules and ensure that planned work is effectively communicated and adhered to in the microbiology laboratory.
5. Manage Analyst timesheets, holiday and coordinate all laboratory events and manage laboratory audits and findings in the microbiology laboratory.
6. Manage Analyst training curriculum and maintain and update all laboratory and analytical documentations in the microbiology laboratory.
7. Manage and maintain all laboratory software in the microbiology laboratory.
8. Troubleshoot all QC analytical methods, equipment and calibrations in the microbiology laboratory.
9. Support continuous improvement in the laboratory and identify gaps in the current QC processes related to microbiology laboratory and plan improvement/ implementation with the QC Manager.
10. Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards.
11. Manage the QC laboratory waste program in the microbiology laboratory and ensure that all QC generated waste are properly segregated and disposed.
12. Manage all laboratory OOS, OOT, deviations and change controls in the microbiology laboratory and liaise with QA etc.
13. Be responsible for equipment qualification, calibration and maintenance in the microbiology laboratory
14. Be responsible for all method validations in the microbiology laboratory
15. Provide assistance to QC Manager related to Technical Agreements in the scope of QC Laboratory
16. Provide support to QC Manager in the scope of realisation of the stability studies program of the company
17. Be familiar with Eudralex Vol IV and other related directives and regulations especially those related to QC work.
18. Manage sampling plans and retained sample management
19. Organize, manage and execute chemical and physical testing/ batch analysis
20. Out of Specification (OOS) result investigations and trending
21. Participate in approval of in-process controls
22. Calibration verification of QC equipment in the microbiology laboratory
23. Responsible for management of reference standards
24. Responsible for qualification of QC equipment in the microbiology laboratory
25. Participate in complaints analysis
26. Organize, manage and execute testing of validation samples in the microbiology laboratory
27. Contribution to raw material supplier approval for microbiology laboratory
28. On request of QC Manager provide Assistance in audits of contract labs
29. Participate in Quality Agreement evaluation
30. Participate in Annual Product Review (APR) data compilation
31. Continually assure Pharmacopoeia reviews related to the microbiology laboratory
32. Participate and manage Statistical Process Control (SPC) / Statistical Quality Control (SQC)
33. Participate in the Environmental monitoring
34. Participate in the global specification standardization
35. On request of QC Manager, participate in Analytical Development either as part of QC or separate organizational unit (e.g. method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting)
36. Participate inanalytical method transfersin the microbiology laboratory
37. Participate in supplier or vendor audits, qualification related to QC activities in the microbiology laboratory
38. The authorization of written procedures and other documents, including amendments related to QC testing in the microbiology laboratory
39. QC microbiology laboratory premises hygiene.
40. Responsible for the retention of relevant records in the microbiology laboratory.
41. Responsible for the monitoring of compliance with the requirements of Good Manufacturing Practice in the microbiology laboratory
42. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
43. Any other duties assigned by the QC Manager related to the pharmaceutical industry
1. Work experience – minimum 1 year at QC Microbiology management positions, minimum 3 years of overall experience in pharmaceutical production company.
2. Education – pharmacy, technology, chemistry, laboratory quality control, microbiology
3. Technology skills (IT Skills)
• Microsoft Office package (Word, Excel, Power Point)
4. Key skills
• Excellent technical skills
• Good numerical skills and an understanding of statistics
• Leadership skills
• Planning and organization skills
• Communication and interpersonal skills
• Problem-solving skills
• Team working skills
• IT skills
• Must also be able to handle responsibility and the pressure of meeting deadlines.
5. Language skills
• Farsi, English (fluent reading, writing, speaking)
6. Certificates and honors
• Master degree or specialization in pharmaceutical Microbiology Quality Control and/or certificates and knowledge about QC and QMS standards in pharmaceuticals is an advance
7. Personal Comments
Shift and 'on-call' work may be required, particularly where manufacturing/production equipment is in continual 24-hour operation.
8. Reporting to: QC Manager