QA

Specifications, Method Validations / Transfers, Investigations, Audit Trail, Stability, Batch Release, Analytical, Molecular & Bioassay Techniques.

Qualification of equipment & Documentation, IPQA, QMS-Ohange Control CAPA, Deviation, Process Validation, Cleaning Validation, APQR, Audit Compliance.

Operation of Blister machines. Troubleshooting, BQS Cartonator: Operation of Cartoning machines. Troubleshooting

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

The purpose of the QA Manufacturing Inspector position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures.

M.Sc / M.Pharma; Audit facilitating and compliance report preparation. Ensuring Compliance in Production, Warehouse, Engineering facility and QC lab. Daily Plant Round for compliance monitoring.

Knowledge of global and regional pharmacovigilance regulations. Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.

Design, execute, develop, and optimize upstream process for biosimilars monoclonal antibodies, fusion proteins in CHO Cells. R&D USP Mammalian, R&D Analytical, R&D Bioassay

Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.