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M.Sc / M.Pharm in Life Sciences / Biotechnology / Microbiology / Biochemistry or related field. Axxelent Pharma Science

To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India. Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.

To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.

Hands-on experience in XRD, DSC, TGA, Microscopy, Zetasizer and PSA; Responsible for day-to-day laboratory activities and team leadership; Experience in GMP-compliant laboratories and QMS.

Knowledge about troubleshooting and experience in handling FETTE & SEJONG compression machines. Required exposure in regulatory audits. 

Experience in analysis of FP, IP, RM, PV and stability samples, and method validation and method transfer. Ajanta Pharma

Compounding | Vial Washing | Filling | LYO | QMS | Aseptic Filling | Visual Inspection | Packing Operators | Blister | Labeling | Granulation | Compression | Coating

Perform analysis of raw materials and in-process/finished products using : UV, IR, HPLC, UPLC, GC, LCMS etc. 

RPG Life Sciences, a part of RPG Enterprises, is an integrated pharmaceutical company operating in the domestic and international markets in the Branded Formulations, Global Generics and Synthetic APIs space.