To prepare documents like BMRs. BPRs. protocols and reports for trial batches, scale-up batches, exhibit batches, process validation batches. To-coordinate and execute scale up, exhibit, process validation batches. To prepare and review the departmental standard operating procedures.
Expertise in sterile compounding processes, including CIP, SIP systems, component preparation, and sterilization. Hands-on experience In aseptic operations, media filling, sterilization processes, and area monitoring.
Environment Monitoring, QMS, Routine and Non-Routine Analysis, PET, Sterility, BET and Water Testing. QMS, IPQA, AQA, Qualification, Process and Cleaning Validation, Aseptic Core Monitoring
Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.
Candidate should have knowledge of FG, HPLC, AAS, Potentiometer and related instruments for stability section. Candidate should have knowledge of IPQA activities in packing and manufacturing areas. Responsible for documentation and cGMP guidelines.