Officer / Executive / Assistant Manager / Manager - Quality Assurance
Job Description:
1. To perform all the activities of Quality assurance departments.
2. Ensure that SOPs are available for all quality related activities and they are current.
3. Prepare and review all quality assurance related documents such as SOPs, log book, format, etc.
4. Responsible for the Release of the final products.
5. Review batch sheet, packing sheet and final product release document.
6. Ensure the implementation of Good manufacturing practices.
7. Ensure implementation of documentation system in the Quality control, Quality Assurance, Production, Engineering, Ware House, and other relevant departments.
8. Ensure retention of all records relating to the manufacture, testing and packaging of the products.
9. Prepare department organogram.
10. Issuance of all quality assurance related document and also manage record for retrieval record for document.
11. Prepare the annual product quality review for the entire product.
12. Prepare the SOP and format related quality assurance department.
13. Review of deviation and change control activities and issuance of related document.
14. Prepare the internal audit document as per schedule and necessary corrective & preventive action is taken.
15. Act as quality representative for Quality related activities.
16. Responsible to maintain the stock of QA department.
17. Responsible to give GMP training.
18. Responsible for new employee training.
19. Review vendor qualification document.
20. To participate in equipment qualification and process validation programme.
21. To undertake any other job as may be assigned by the Lead quality assurance.
22. Review the deviations and OOS are investigated and necessary corrective and preventive actions are implemented
23. Responsible to maintain AVL and coding list.
24. Responsible to fill vendor qualification documents and give response to vendor query.
25. To prepare internal audit schedule and to implement.
26. To prepare training schedule and its effectiveness.
27. Responsible to review of finished product analysis data.
28. Responsible to take follow up for calibration, maintenance schedule.
Company Profile
For almost a century, SK has impacted millions of lives across the globe whilst creating a brand that resonates with a sense of trust and strong ethical business values. Established in 1932, The SK Group is involved in a number of businesses within the pharmaceutical industry today. Over the years, the SK Group has grown from a single chemist shop to over a dozen independent entities, from a single entrepreneur to a leadership team comprising of three generations of a family and from being a small distributor to global leaders in the fields of APIs, formulations, logistics, distribution and R&D.
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