M.Pharma from a recognized university or equivalent. M.Sc. Biotechnology / Microbiology from a recognized university or equivalent. Working knowledge in the area of Biotechnology.
Post Graduate Degree, including the integrated PG degrees, with five years’ post qualification experience or PhD plus two years post qualification experience.
Individuals desirous of seeking admission to PhD program at NIAB must have a Masters degree (M. Sc., M. Tech., M. V. Sc. or M.Pharm.) or MBBS or B.Tech. (four-year) degree in any branch of Life Sciences.
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority.
Performs testing not only of raw materials and drug products, maintenance and calibration of analytical instruments, prepares standard and sample solutions and maintains appropriate records. Carry out checks of record documentation.
Assist in conducting and reporting audits for Sun Pharma sites associate with Pharmacovigilance activities/ operations to assure adequacy & adherence with established Quality Systems.
Develop stability study designs for new product development and sustaining product projects. Contribute to technical feasibility analysis of complex research and design concepts. Evaluate results relative to product requirements, definitions and/or program goals.