Execution of batch process as per batch processing record in Granulation, Compression and Coating, Packing. Execution of equipment operation & cleaning activities as per SOP
Experience in operating and cleaning a Vial Washing machine, Oepyrogenation Tunnel, Automatic Vial Filling and Sealing Machines, and Automatic PFS filling machines
M.Pharm. QMS/AQA/IPQA/ Validation/Documentation. Candidates should have experience in Formulations regulated manufacturing company such as USFDA & MHRA. Exposure to regulatory audits like USFDA, MHRA is mandatory
Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
M.Sc, M. Pharma, B. Pharma. Analytical methods validation, verification and methods transfer. Validation of cleaning methods. Handling HPLC, GC, DR and other instruments. Preparing method validation verification protocol and report. Reviewing analytical hard copy and electronics data.
As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval.