1. Demonstrate strong leadership and management skills, communicate effectively, manage multiple workloads and coordinate all QC activities with the Senior Quality Manager.
2. Work closely with all departments including the commercial and logistics departments to help understand customer requirements and plan the timely testing and release of product batches and assist with the review of all QC analytical data and ensure that right first Time KPIs are achieved.
3. Install a KPI system
4. Manage and schedule routine and annual maintenance, troubleshooting and of all analytical equipment and analytical practices and procedures in order to uphold continuous improvement.
5. Manage Analyst work schedules and ensure that planned work is effectively communicated and adhered to.
6. Manage Analyst timesheets, holiday and coordinate all laboratory events and manage laboratory audits and findings.
7. Manage Analyst training curriculum and maintain and update all laboratory and analytical documentations.
8. Manage and maintain all laboratory software.
9. Troubleshoot all QC analytical methods, equipment and calibrations.
10. Support continuous improvement in the laboratory and identify gaps in the current QC processes and plan improvement/ implementation with the QC Manager.
11. Act as a primary contact for laboratory related queries and liaise extensively with internal and external customers.
12. Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards.
13. Manage the QC laboratory waste program and ensure that all QC generated waste are properly segregated and disposed.
14. Manage all laboratory OOS, OOT, deviations and change controls and liaise with QA etc
15. Be responsible for equipment qualification, calibration and maintenance
16. Be responsible for all method validations
17. Be responsible for Technical Agreements related to the department
18. Be responsible for the stability studies program of the company
19. Be familiar with Eudralex Vol IV and other related directives and regulations especially those related to QC work.
20. Sampling plans and retained sample management
21. Chemical, microbiological, biological, and physical testing/ batch analysis
22. Out of Specification (OOS) result investigations and trending
23. Specification approval
24. Release of raw materials, packaging components, in process materials
25. Approval of in-process controls
26. Calibration verification of QC equipment
27. Management of reference standards
28. Qualification of QC equipment
29. Stability program, controls and testing
30. Complaint analysis
31. Testing of validation samples
32. Contribution to raw material supplier approval
33. Assistance in audits of contract labs
34. Quality Agreement evaluation
35. Annual Product Review (APR) data compilation
36. Pharmacopoeia reviews
37. Supplier testing approval
38. Statistical Process Control (SPC) / Statistical Quality Control (SQC)
39. Environmental monitoring
40. Global specification standardization
41. 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)
42. To participate in analytical method transfers
43. Participate in supplier or vendor audits, qualification related to QC activities
44. The authorization of written procedures and other documents, including amendments related to QC testing
45. QC premises hygiene.
46. The retention of relevant records.
47. The monitoring of compliance with the requirements of Good Manufacturing Practice in the QC department
48. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
49. Any other duties assigned by the Quality Senior Manager related to the pharmaceutical industry
1. Work experience – minimum 2 years at QC management positions, minimum 3 years of overall experience in pharmaceutical production company.
2. Education – pharmacy, technology, chemistry
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 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: Senior Manager for Quality