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Having Injectable Experience of Shop floor activities like Vial washing and Depyrogenation, Filling and Sealing, Autoclave, Garment washing machine, Lyophilizes

M.Sc, M. Pharma, B. Pharma. Analytical methods validation, verification and methods transfer. Validation of cleaning methods. Handling HPLC, GC, DR and other instruments. Preparing method validation verification protocol and report. Reviewing analytical hard copy and electronics data.

M.Pharm, B.Pharm, M.Sc, B.Sc; Responsible for accurate production and packaging changeovers as per packaging schedule. Maintain a clean work area and clean equipment before and after shift.

Must have experience in the development of nasal spray, nebuliser and other respiratory dosage form. Exposure of regulated and domestic product development

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

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.

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

Responsible for designing overall marketing and communication strategy of brands. Sales & Market data analysis. Knowledge of product strategy, product launch.