2-3

Experience in IPQA,QMS, Qualification & validation. Must having experience of API Pharma Industries.

Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval

Environment monitoring of aseptic area, Water sampling and testing, Sterility testing, Bioburden analysis and MLT analysis, Bacterial endotoxin test, Media preparation and handling.

Skilled in Batch Records, SOPs, BMR, and validation documentation. Proficient in calibration, routine equipment checks, and troubleshooting.

Good understanding of medical affairs function. Understanding of local regulatory policy and industrys code of practice related to drug registration, pharmaceutical promotion and clinical research.

Aurobindo Pharma Limited is an Indian multinational pharmaceutical manufacturing company headquartered in HITEC City, Hyderabad, India

Ability to handle process like Dispensing, Granulation, Compression, Coaling, Responsible for online documentation & QMS.

Line clearance for Upstream and Downstream manufacturing operations. Line clearance for sterile bulk antigen manufacturing.

Responsible for executing technology transfer activities for injectable dosage forms, including planning and performing Scale-up, Exhibit and Process Validation batches with optimal utilization of manpower, materials, and equipment.