Exemed Pharmaceuticals Job Vacancy For QA
Department: Quality Assurance
Position: Executive and Sr. Executive
Location : VAPI ( Formulation Unit)
Experience 5-8 years and above
No. of vacancies – 2 Nos.
CTC : 5-7
Email Id- corporate.hr@exemedpharma.com
Responsibilities:
1. Handling and closing of change control, incidents, deviation, OOS, OOT, CAPA and market complaints.
2. To impart training to all departments whenever required.
3. To prepare the schedule, review and execute Self inspection as per the SOP for all departments.
4. To assist in continual upgrading in documentation system (QMS).
5. To support in preparation and implementation of SOP’s, PV, Trial protocols at Plant level as per GMP Guidelines and Quality Policies and final approval.
6. To review Analytical Method Validation, method transfer and process validation as per regulatory guidelines /In-house requirement.
7. To assist in customer and regulatory audit, customer audit handling & preparation of response.
8. To release of finished goods, RM, PM when required.
9. To handle vendor management related activities.
10. To review and approval of OOT, OOS, Failure investigation & Root cause Analysis.
11. Review and release batches of Finished products and API.
12. To ensure technical transfer of the documents for new product introduction.
13. To support for products preparation and review of SMF, VMP and validation activities.
14. To guide for preparation of Cleaning validation documents.
15. To ensure the all qualification of processes through approved documents
16. Assure periodic Qualification HVAC, water system and so on.
17. Responsible for review and evaluation of APQR
18. To Review of Environmental monitoring in microbiology lab, pharma plant and API Plants as per respective SOP.
19. To Review the microbial limit test report, calibration report and other related reports of microbiology department.
20. To Review trend data for water and environment monitoring.
21. Hands on experience on cleaning validation
22. Responsible for review of batch records
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