ADL

Ensure documentation, compliance, and regulatory readiness in various section like IPQA, QMS, Qualification related activities. Design, develop, and optimize new drug formulations of OSD, Ointment and Injectable.

B.Pharm, B.Sc, M.Sc. OSD - Coating, Compression, Granulation, Ointment-External Preparation General Manufacturing and Sterile Manufacturing. IPQA - OSD and Injectable, AQA, APQR, Documentation, Validation, QMS, CQA, Artwork. Injectable, Aseptic, SIP, CIP, Batch Manufacturing, Bulk Manufacturing, Dry Powder, Oral Liquid. HPLC Operating, Dissolution, Assay

Analytical Method Development, Validation, Transfer activities of test like Assay, RS, Dissolution and Solvent. Calibration of the Analytical instruments like HPLC, GCHS, IR, UV & Disso as per the master calibration schedule.

Should be able to develop analytical methods and perform analysis on UV, Dissolution, HPLC and ICP-OES instruments. Dissolution development, Comparative dissolution profile and multimedia dissolution study.

Person should be well experienced in Environment Monitoring of Injcetable facility Settle plate, air sampling, surface monitoring and personnel gown monitoring. He must be aware of good documentation practices and aseptic behavior.

HPLC, GC, IC method development, feasibility, verification, equivalency, validation for API, complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets

HPLC, GC, IC method development, Validation and Transfer for API, complex OSD, complex generics products like long acting injectables, nasal sprays, peptide injections, peptide OSDs, oncology and Topical products etc using various analytical technique. Expertly in peptide characterization. Well versed with USP/EP/BP/IP and various current regulatory guidelines ICH/ EMEA/ FDA Hands on experience on Nitrosamine and Genotoxic impurities method development, M.Pharm / M.Sc

Analytical Method Development, Validation, Transfer activities of test like Assay, RS, Dissolution and Solvent. Calibration of the Analytical instruments like HPLC, GCHS, IR, UV & Disso as per the master calibration schedule. Carry out routine analysis & Ensure documents pertaining to day to day analysis.