Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world. Headquartered in Hyderabad, India, Granules offers collaborative and strategic partnership to global pharmaceutical leaders by producing best quality API, PFI and FD through manufacturing excellence, process innovation and regulatory expertise.
WALK IN INTERVIEW Production, Warehouse, Engineering & IPQA (OSD Formulations)
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.
Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating. Capsule filling. Expertise in e-BPR and e-log will be added advantage.
Knowledge having batch observations,readings, environmental conditions, labeling, weighing. Inprocess checks and other required observation before,during, after In each compression and Bin feed area, coating and Inspection area., submission of SOPs, BMRs,Records,logs,labels etc., SOP Related Trainings
Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP .Ready to work in rotational shift.
To supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches.
Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and, or regional perspective.
Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.