Senior Executive

Role & responsibilities

1. Responsible for monitoring of basic norms of cGMP, ALCOA+ Principle, data integrity, GDP & to maintain his personal health hygiene.

2. To co-ordinate and carry out the self inspection and maintain records of self inspection report, schedule, auditor List, Auditor Qualification, compliance status etc.

3. To prepare, review and implement various protocol and report like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area / Equipment), Equipment / Instrument / System Qualification, Hold time Study.

4. To execute various activity like Process Validation, Cleaning validation, HVAC validation, Temperature Mapping (Area/Equipment), Equipment / Instrument / System Qualification, Hold time Study as per schedule and protocol.

5. Process Validation, Cleaning Validation & Hold Time study sample management and execute Process Validation, Cleaning Validation & Hold Time study schedule.

6. To prepare, review and maintain records for internal/external audit compliance.

7. To prepare / review investigation related to Market Complaints, Deviations, OOS, OOT and Queries received from the customers and regulatory department.

8. To operate SCM, EDMS, Track wise software and different types of software for daily activity.

9. To ensure that the required initial and continuing training of the departmental personnel is carried out as per training calendar and adapted according to need.

10. To Monitor and maintain External calibration records/ certificates of instruments and equipment.

11. To prepare SMF,VMP, Quality Manual and maintain their record.

12. To prepare and carry out Risk Assessment for various activity.

13. To compile data for monthly report of QA,Quality Report and Quality Metrics.

14. To review Product Quality Review of various products.

15. To monitor and review Vendor Qualification Documents.

Preferred candidate profile

B. Pharm / M. Pharm / Msc candidate with 8-10 years of experience can share their profile on sanjay.hrtrp@vsinternational.co.in