For a pharmaceutical formulations plant manufacturing Liquids, Capsules, Tablets, Injectables, Soft-gel & Powders, located in SEZ, Nallore Dist; Andhra Pradesh (65 kms from Chennai), exporting to more than 50 countries....
01. Overall Incharge for Total Quality management system for all operations having an impact on quality of the process and final product.
02. Responsible for coordination and compliance for various regulatory inspections.
03. Responsible for the review and approval of plant documentation, compilation for submission to regulatory requirements.
04. Responsible to coordinate the plant management quality review meetings and Site transfer of technology.
05. Responsible for assessment and final approval of all Change Controls and monitoring of changes.
06. Responsible for the final approval of the product for dispatch after reviewing all the quality records. (Batch Manufacturing and packing Records, In-process Quality Control records, COAs, and other related batch records like deviation/investigation reports).
07. Responsible for the coordination of the cGMP and on the job training of the plant personnel.
08. Responsible for the initiation, review and assessment and final approval of deviations, non-conformances, Out of specifications.
09. Responsible for monitoring of all quality related activities and for the review & approval of Annual product quality review documents.
10. Responsible for the approval of the standard operating procedures, standard testing procedures, General Testing Procedures, Validation protocols, Master Formula Records, batch records (BMR,/BPR) and all other Master documents viz., Site Master File, Validation Master Plan, Training Manual and Quality Manual .
11. Responsible for total documentation control through proper change control system.
12. Responsible for the approval of validation studies of the process / Cleaning / Facility / Equipment / Instrument.
13. Responsible for the approval of investigation and findings of market complaints.
14. Responsible for the coordination incase of product recalls.
15. Responsible for the GMP monitoring in the plant and approval of self-inspection reports.
16. Responsible for the timely updation of the documents inline with the current regulatory guidelines.
17. Co-ordination with QC, packaging development and marketing departments for generation and approval of artwork.
18. Responsible to review and Approve the technical Agreements.
19. Responsible for the identification of Crisis situation, act accordingly and ensure compliance.
20. Periodic assessment of the vendors through vendor audit and vendor approval.
21. Plant operations in monitoring and control of manufacturing environment, plant Hygiene and GMP compliance in the plant.
22. Joint responsible with QC in assessment and conclusion of stability studies.
To manage and face Regulated Audits like US-FDA / MHRA / WHO-Geneva / TGA / EU
M.Pharm / B.Pharm /M.Sc graduates with 12+ years experience in Quality Assurance functions for pharmaceutical formulations, experienced in facing regulated market audits like US-FDA / MHRA / WHO-Geneva / TGA / EU etc, who is at DGM-Q.A or above position at present with a reputed pharma company exporting finished formulations to the regulated and semi-regulated markets.