Perform analysis of raw materials and finished products using UV, IR, HPLC, UPLC, GC, LCMS, etc. Ensure adherence to SOPs, GMP, and ALCOA principles during shift operations.
Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents.
Executing chemical reactions in mg to gm scale and to synthesize required quantities of molecules/compounds as per client specifications using efficient route and techniques.
Good Exposer On Life Cycle Management, Handling Post Approval & Pre approval, Knowledge on MAA (Marketing Authorization Application), Experience in CMC, Variations.
Dossier & document preparation as per CTD, ACTD & country specific guidelines, Review of dossiers, DMF & Technical documents, Answer query raised from regulatory authority.
Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry.