Ph.D. degree in any branch, specialization in Pharmaceutical Sciences from University of repute. Masters degree in appropriate branch of specialization in Pharmacy with Bachelors degree in Pharmacy with minimum 60% marks or equivalent.
Monitor the API, formulated products against stipulated conditions mentioned in the batch production record. Conduct certification of batch production records for compliance and stage wise completion.
Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission. Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist
B.Pharm, M.Pharm, B.E, B. Tech with 6 to 10 years of experience in Supervising and Controlling Production areas like Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, Visual Inspection and Packing. Should have knowledge of QMS activities
Prepares, literature review, abstracts, posters, and slide sets, and Manuscripts sophisticated working from various data sources including clinical study reports, patient profiles, protocols etc.
Expertise of Finish goods testing. Stability, RM Analytical Method Validation, Dissolution, HPLC, PMQC and knowledge of handle other sophisticated instruments like GC, XRD, ICPMS, LCMS.
Responsible for process validation and cleaning validations and respective documentation. Responsible for Equipment and utilities qualification and periodic validation.