Themis Medicare invites applications for Regulatory Manager - QA
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: Regulatory Manager - QA
1) Periodical internal self-Auditing of the API plant, Research center & external auditing of raw & packing materials, towards compliance, everything concerned to the quality of product entering into regulatory markets to match the international regulations / standards & strict requirements.
2) Quality Compliance Activities related to
I) API development Synthesis lab
II) API development Analytical lab
III) Quality Control Development
3) Search the patent for the existing generic API and their synthetic route.
4) Maintaining the Quality management .
5) Review and approve BMR, Analytical Reports and All Technical documents like specifications, development reports, method validations etc.
6) Evaluation of the changes, investigation of deviations and Quality compliance activities, OOS, OOT, BMR and BPR etc.
7) Conduct the trainings on the GLP as per the requirement of the associates to improve the awareness.
8) Support product transfer activities.
9) Provide technical support service to sales & marketing, answering customer technical enquiries, recommending products, role holder communicates with production, R&D, technical, sales and marketing contacts both internally and externally, and support R&D, Quality Assurance, and Quality Management.
10) Follow GMP practices and Sops, Review records and tracking of data.
Good communication skill.
Ready to accept new challenges,
Good team member, having an ability to build a productive working relationship.
Good understanding & representative qualities.
Experience: 2 - 5 Years
Education: B.Pharma, M.Pharma
Industry Type: Pharma/ Biotech/Clinical Research
Role: Analytical Chemistry Associate/Scientist
Functional Area: Healthcare, Medical, R&D
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