To ensure cGMP compliance at the shop floor for Drug Substance (DS) manufacturing through effective line clearance, documentation review, in-process oversight, and quality systems activities.
Case Intake, Data enter, Quality review information received pertaining to the case in the database. Refer to the Data entry conventions for any questions while entering the data.
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm
The Senior Pharmacovigilance Safety Scientist, Benefit Risk is expected to be professional and diligent and liaise with the director and management group members within the team on any issues, as well as coordinate the work with the senior PV Scientists. Pharma, Life Science candidates to Join ProPharma
Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz
Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines. Amgen
Finished Products, Stability Studies, Instrumental Analysis (GC, HPLC, KF), Raw Material. Alkem Laboratories Limited is organizing a walk-in interview drive to source candidates for its Baddi manufacturing facility.