Pv - QA (8+ Years)

21 hours ago

Sama Vadodara Gujarat, India Novumgen Full time

**Roles and Responsibilities**:
1. To prepare and review QA related SOPs/Manuals/Policies.

2. To review PV SOPs and Management of all SOPs/Manuals/Policies for PV and QA

Department.

3. Management of Change control forms
- Issue, Chage control no., Implementation and post implementation.

4. To ensure effective conduct of trainings at PV and QA department for new joiners and existing employees.

5. To ensure the management of training plans, CV, JD and training conduct as per SOP of

Training.

6. To prepare audit plan for Tactical audit, Strategic audit and Operation audit and to conduct the audits.

7. Management of Vendors (Vendor qualification) - Audit agenda, Audit plan and audit conduct as per scheduled plan.

8. To review ICSR and submission to meet the timelines periodically or as and when required, Risk management plan as and when required, PV activities trackers, Monthly compliance report.

9. To check audit trails of PV safety database for risk assessment of software periodically or as and when required.

10. To review signal management activity and periodic safety reports submission as a part of Pharmacovigilance audits meeting KPI of PV activities.

11. To review and audit PSMF and its appendices management in line with SOP.

12. Other retrospective review on request of PV department (as and when required).

13. To review and proved inputs for SDEA, PVA and any other agreements.

14. To review or approve Computerized system qualification record.

15. To discuss audit and training compliance with respective QPPV.

16. Management of Deviation and CAPA- Issuance of forms, proposed corrective and preventive actions, Allocation of CAPA/Deviation number, effective Deviation/CAPA closure, Tracking of Deviation and CAPA.

17. Management of Documents
- Handling of Master, control and uncontrol documents, Issuance of the documents as per requirement, Controlling of the documents etc.

18. Record keeping and archival of documents, Management of electronic data archival as

requested from PV department.

19. To conduct or assist the quality risk management activity as and when required or applicable.

20. To assist and review computerized system qualification documents and system

implementation.

21. To review documents of mock test for business continuity plan as and when applicable.

22. To ensure compliance of data protection policy as part of PV audits and periodically as

applicable.

23. To assist or host client audits, external audits and regulatory inspections and to assist or

respond to audit observations as and when needed.

24. To provide response to observations from partner or regulatory for PV.

25. To discuss audit compliance with Management as a part of PV department quality

compliance.

26. Any other task delegated by Management

Pay: ₹500,000.00 - ₹1,000,000.00 per year

Work Location: In person

**Speak with the employer**
+91 7862850154

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