Position Title Sr Manager Assistant General Manager -Corporate Quality Assurance Department Quality Assurance Location Corporate Office with oversight for Daman Tarapur Jammu Plants Role Purpose To ensure consistent implementation of Quality Assurance systems compliance to global regulatory requirements and continuous improvement across all manufacturing sites Daman Tarapur and Jammu The role drives harmonization of quality processes oversees audits and regulatory inspections and ensures adherence to cGMP and corporate quality policies Key Responsibilities Oversee the Quality Management System QMS implementation across multiple manufacturing sites to ensure alignment with corporate and global quality standards Ensure compliance with international regulatory agencies such as USFDA MHRA WHO-Geneva TGA and other market-specific authorities Lead internal and external audits including mock inspections and support sites during regulatory audits Review and approve corporate SOPs validation protocols and product quality documents to maintain standardization Monitor key quality metrics deviations OOS OOT change controls CAPA effectiveness and drive root cause analysis with respective site QA teams Establish and maintain corporate-level quality risk management change management and documentation control systems Collaborate with R D Manufacturing and Regulatory Affairs to ensure new product introductions meet global compliance standards Conduct periodic reviews and management presentations on compliance status audit observations and continual improvement initiatives Lead training and capability-building initiatives for site QA teams to strengthen compliance culture Support in vendor qualification technology transfers and contract manufacturing site audits from a corporate QA standpoint Key Performance Indicators KPIs Regulatory compliance score and audit outcomes Reduction in critical and major audit observations Timely closure of CAPAs and deviations QMS harmonization and standardization across sites Training completion and effectiveness scores for QA teams Desired Candidate Profile Education B Pharm M Pharm M Sc Chemistry or related discipline Experience 18-25 years of experience in Quality Assurance within the Pharmaceutical industry preferably in a corporate or multi-plant QA role Solid exposure to international regulatory audits USFDA MHRA WHO TGA Proven expertise in QMS validation documentation and data integrity systems Technical Skills Excellent understanding of cGMP ICH and global quality guidelines Proficient in handling quality investigations CAPA management and audit readiness Sound knowledge of regulatory documentation quality risk management and data integrity principles Job Type Full-time Pay 2 200 000 00 - 3 100 000 00 per year Work Location In person

📌 Sr. Manager / Assistant General Manager –corporate Quality Assurance (Maharashtra)
🏢 LyfLeap Talent Solutions Private
📍 Maharashtra