Having Injectable Experience of Shop floor ac-tivities like vial washing, compounding, filtration, filling and Sealing, Autoclave, Garment Washing machine, Lyophilizes
Must be from Formulation Industry. Undertake method development, troubleshooting and method validation to GMP and ICH. Investigation of non- conforming samples, CAPAs, data evaluation and reporting.
Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.
Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.
End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.
Ability to conceptualize and drive large-scale marketing strategies with an execution-first approach. Experience in leading teams, collaborating with sales, and driving prescription demand at a national level.
Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review.