Work as Manager - QA in 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: Manager QA (API)

Job Description:
• Ensuring high standard of quality in all areas of manufacturing of API plant as per USFDA and other regulatory agencies.
• Exposure of Handling various audits for regulated market like : WHO, USFDA, EDQM etc.
• Exposure of handling various Customer audit.
• Supporting manufacturing functions through implementation of current Good Manufacturing Practices (cGMP) and Quality Assurance Systems.
• Preparation of Master validation plan, Site Master File, Standard Operating Procedures (SOPs), Specifications, Quality System Procedures, Quality System Manual.

• Training of personnel on various aspects of current Good Manufacturing Practices (cGMP), Good Documentation practices (GDP) and Good Laboratory Practices (GLP).
• Product Quality Reviews, Internal Quality Audits, Implementation Quality Systems.
• Validation of Equipment’s, Process validation, Cleaning validation, AHU validation, Water system validation and Facility validation as per international regulatory guidelines.
• Preparation of registration documents as per the guidelines of USFDA, EDQM and Various Registration Documents for Product Registration.
• Handling of Market complaint, Change control, Deviation, OOS, Failure investigation and CAPA.
• Customer support and troubleshooting.

Candidate Profile:
i. Strong interpersonal relations communication and man management skills.
ii. A team player and a strong ability to lead a group.
iii. Conversant with cGMP norms and the USFDA rules and regulations.
iv. Ability to conduct internal audits and face inspections from regulatory agencies.

Additional Information:
Experience: 10-20 Years
Location: Hyderabad
Education: B.Pharma, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 4^th Feb, 2012