Posted:6 days ago|
Platform:
Work from Office
Full Time
1. Responsible for implementation & monitoring of cGMP/GDP practices at site.
2. Responsible for periodic review of all quality Documents for appropriateness.
3. Preparation of SOPs and handling of QMS tools like deviation change control, CAPA.
4. Responsible for approval/rejection of deviations /change controls pertaining to corporate activities.
5. Oversee the team of technical personnel handling order processing artworks finalization BOM updating of products and follow ups.
6. Responsible for co-ordination and submission of Quality documents for regulatory submissions.
7. Responsible for maintenance, periodical update and review of technical agreements with domestic and overseas customers.
8. Coordinate the activities of plant GMP inspections/audits by regulatory authorities, MOHs and clients and support compliance response submissions and follow up on closure of audit observations.
9. Responsible for management of annual product reviews as per schedule.
10. Monitoring monthly management review meetings and report circulation of the report.
11. Monitoring/Participation in self-inspections or quality audits for effectiveness and applicability of quality system.
12. Monitoring of training program calendars in place and execution status.
13. Responsible for evaluation and investigation of product complaints received at Medopharm Private Limited.
14. Participate in investigation for field alert or product recall.
15. Coordinate with all connected departments like Regulatory, purchase, planning, Artwork, plant QA and other departments.
16. Responsible for activities related to compliance management cell at the site.
17. Responsible for tracking of CAPAs and its implementation status.
18. Responsible for tracking of regulatory commitments and it implementation status.
19. Responsible for GMP spot checking on shop floor to verify effectiveness of implemented Actions.
20. Responsible for complaint investigations.
21. Responsible to facilitate implementation of regulatory updates.
22. Responsible for performing spot challenge studies for GMP activities at the site.
Candidate should have good communication skills and Pharmaceutical OSD Experience required
Medopharm
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