Gujarat

Review all data and documents related to product registrations for various health authorities. Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia

Exposure in investigation of UPD , OOS, OOT, EM and Change control & CAPA Management. Preferable for exposure in Regulator}’ and FDA Audits, Knowledge and exposure for aseptic operations and principal of its relevant equipment.

2-7 years of experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic and control area operation, documentation, both SVP and LVP manufacturing etc.

Investigation Tools, 5Y, Fish Bond, 6M, QMS Activities, Change Control, Deviations, CAPA, Monthly MIS Data. IPQA - OSD and lnjectable, AQA, QA Stability, APQR, Documentation, Validation, QMS, CQA, Artwork

B. Pharm, M. Pharm, B.Tech. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.

Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP .Ready to work in rotational shift.

To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.

Establishment of procedures to ensure adherence to trial protocols and administrative requirements. Ensuring the timely recruitment of trial participants with secure randomization processes and subsequent efficient and effective data management.