Requires M Pharm Freshers/Experienced for a Pharma Manufacturing Plant @ Sance Laboratories Pvt Ltd, Kottayam, Kerala "P"

Job Description

1. Reviewing all procedures influencing product quality.
2. Reviewing changes that potentially affect product quality.
3. Confirming the plans and results of process validation.
4. Control samples storage, controlling, issue and destruction.
5. Preparation and control of Monthly department functional report to management.
6. Reviewing all manufacturing instructions, completed batch records and laboratory control records of critical process of concerned lots when deciding the release of products to market.
7. During review of manufacturing documents making sure that the critical deviations are investigated and resolved.
8. Review of following document being the part of Doc. cell
a) Filled BMR/BPR/BAR.
b) New and Revised Standard Operating procedure.
c) Filled change control.
d) Filled Deviations.
e) Filled NCRs.
f) Investigation reports.
g) Self inspection reports.
h) Retrieved documents from all departments.
i) Calibration records.
9. Preparation of following documents
a) New and Revision of MFR.
b) New and Revision of BMR/BPR.
c) New and Revision of SOPs.
d) Process Validation protocol and report
e) Cleaning Validation protocol
10. Handling of market complaints
11. Handling of OOS
12. Handling of Specimen signature
13. Preparation of APR, Annual Trend sheet
14. Protocols preparation for qualification of Machinery
15. Handling of re qualification master re qualification program.
16. Handling of Re validation and master re validation program.
17. Provision of Batch No. Mfg. Dt., Expiry Dt. for products.
18. Preparation of Validation Master plan, SOP’s, Process validation protocol, Process validation report
19. Preparation of Facility validation protocols.
20. Failure Investigation

Requirements

Candidate should have completed M Pharm from a recognized university also should have pharmacy council registration certificate.

CLICK HERE FOR MORE INFO