Novetra Pharmaceuticals Pvt. Ltd.

🎯 Role Purpose To implement and execute a robust Quality Management System (QMS) for a dedicated oncology solid oral manufacturing block , ensuring compliance with Schedule M and WHO-GMP during plant commissioning, validation, and regulatory inspections. 🔑 Key Responsibilities Ensure compliance with Schedule M and WHO-GMP requirements. Implement and maintain QMS documentation including SOPs, BMRs/BPRs, logbooks, deviations, CAPA, and change control . Provide QA oversight for solid oral operations: granulation, blending, compression, coating, encapsulation . Execute and document cleaning validation for cytotoxic products , including MACO calculations and worst-case selection. Ensure strict adherence to equipment, personnel, and area dedication within the oncology block. Support equipment, process, HVAC, and utility qualification activities from a QA perspective. Assist in manufacturing license inspections and regulatory audits . Support vendor qualification, raw material QA, and stability study initiation. Conduct GMP and oncology-specific training, including cytotoxic handling and spill management. 🧠 Key Skills Schedule M & WHO-GMP compliance Cleaning validation (cytotoxic products) Cross-contamination control Deviation, CAPA & data integrity (ALCOA+) Audit preparedness & documentation control 🎓 Qualification & Experience B.Pharm / M.Pharm / M.Sc. (Chemistry) 5–7 years of QA experience in solid oral dosage form manufacturing Hands-on exposure to Schedule M inspections and validation activities Oncology or potent compound experience preferred 📊 Reporting Reports to QA Head / Director – Quality (Independent of Production as per GMP) 💰 Compensation As per industry standards, commensurate with experience.