Requirement of Head / VP / GM - QA / QC (Formulation) at Themis Medicare

Themis Medicare is headquartered in Mumbai with four state-of-the-art manufacturing facilities at three locations, in Vapi (Gujarat), Hyderabad (Andhra Pradesh), and Haridwar (Uttaranchal).
Even though, Active Pharmaceutical Ingredients account for a significant portion of Themis Medicare's revenue, the Company is setting new benchmarks in manufacturing and marketing formulations. The company has prudently addressed relevant and growing therapeutic areas like antituberculosis, antimalarials, cardiology, pain management, anti-infectives, haematinics, Health & Nutrition. The company is also engaged in co-marketing its research based formulations with other pharmaceutical companies in India and abroad.

Post: Head/VP/GM-QA/QC

Job Description:
1. Approval, control and distribution of quality documents like SMF, Quality Mannual, SOPs, Validation protocols and reports, Specifications, Method of Analysis and General test procedures
2. Review of SOPs, Non-conformances, Process deviations, Change controls, Market complaints and Product quality review data on regular basis.
3. Preparation of Validation Master Plan/ Calibration plan and implementation of the validation/ calibration schedules.
4. To plan, organize and conduct Self-inspections and arrange Management review meeting to ensure the implementation of proposed corrective and preventive actions.
5. Qualification and Validations of equipment and processes.
6. Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions ( CAPA ).
7. Management of External Inspections and to ensure the deficiency corrections well within the stated time frame.
8. Preparation and Implementation of Training Program.
9. Vendor development and vendor audits for raw materials and packing materials.
10. Loan licensee’s audit for the contract manufacturing.
11. Handling of all regulatory audits with appropriate CAPA for the deficiencies agreed upon.

Candidate Profile:
Good communication skill, always ready to accept new challenges, a good team leader, having an ability to build a productive working relationship. Have good understanding , analytical & representative qualities.

Additional Information:
Experience: 15-25 Years
Location: Haridwar
Education: B.Pharma, M.Pharma, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, QC
End Date: 27^th June, 2011