Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing.
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.
For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
Responsible for process validation and cleaning validations and respective documentation. Responsible for Equipment and utilities qualification and periodic validation.