Job in Themis Medicare as Quality Assurance Manager in API

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: Quality Assurance Manager in API

Job Description:
1) Over all Quality Management System Documentation
2) Training of site staff on quality systems and Current Good Manufacturing Practices(cGMP).
3) Planning, coordinating and implementing internal audit programs like production, ware house, Engineering and QC facilities and coordinate to fill up the gaps as per guidelines (ICH Q7)
4) Qualification of process equipments and utilities like HVAC, water.
5) Involved All Validation activities and its Documentation.
6) Review and approval of Validation Master Plan, Site Master File, and Risk assessment Manual and Quality Manual.
7) Handling of CAPA
8) Handling of deviations, change controls and Out of Specification.

Candidate Profile:
1) Leadership Skills.
2) Sense of responsibility.
3) Excellent skills in communication.

Additional Information:
Experience: 10-15 years
Location: Vapi
Education: B.Pharm, B.Sc
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: QA