Skilled in operating analytical instruments like HPLC, CC, UV, and Dissolution Apparatus. Perform stability studies and microbiological testing as per GMP and ICH guidelines. Hetero Pharma
Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.
Hetero is one of worlds leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector.
The ideal candidate will be responsible for compiling Drug Master Files DMFs and Certificates of Suitability CEPs, ensuring compliance with global market regulations and emerging market standards in accordance with ICF guidelines. This role requires strong coordination with internal stakeholders and expertise in regulatory submissions, amendments, and annual reports.
B.Sc/M.Sc/ B. Pharm/ M.Pharm with relevant experience. HPLC/ IP/ FP/ RM/ Validation/ Stability/ GC/ GLP; Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.