Key Responsibilities
- Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.
- Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents.
- Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations.
- Ensure effective implementation of IPQA, data integrity, quality risk management, self-inspections and audit compliance.
- Approve/review batch release, raw materials, packaging materials, intermediates and finished products.
- Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies.
- Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations.
- Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories.
- Ensure compliance with pharmacopoeial, regulatory and statutory changes and their effective implementation.
- Oversee recent product introduction and technology

📌 Quality Assurance Manager (Kolhapur)
🏢 Immacule Lifesciences
📍 Kolhapur