Qc+dra Executive Required at Baddi, Himachal Pradesh
1 month ago
1. REGULATORY AFFAIRS- FINISHED FORMULATION
2. Preparation and reviewing of administrative documents.
3. Preparation and review of Dossier in CTD, ACTD and ECTD Format.
4. Preparing the SPC/ SMPC as per country guidelines.
5. Preparation of Dossier For CIS, Africa Countries, Gulf Countries and South India Countries
6. Review and making of stability data, Analytical Methol Validation, Process Development record.
7. Review of DMF (Close Part)
8. Review of Labels and literature as per the country guideline
9. Preparation Of COA, MSDS, Packing Specification, Finished Product Specification
10. Should Involved in preparation of SOP's.
11. To Oversite third party manufacturing quality, COA and Control Samples
12. To Co-ordinate with Warehouse, Designer, Cross Functional team
13. Having Experience in handling audit of manufacturing site
14. Making of STP, Manufacturing Flow Chart
15. Prefer From Pharma finished products Background
16. Review of Labels and literature artwork
17. Knowledge of schedule M, FDA, CDSCO
18. Preparation of OF MSDS
19. Preparation and Review of COA
20. Compliance of SOP GMP standards
21. Execution of CAAPA
22. Review of Dossier for different countries.
Pay: From ₹15,027.78 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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