<ul><li>Establish, implement, and maintain a robust Quality Management System (QMS) in compliance with global regulatory guidelines.</li><li>Ensure compliance with cGMP, ICH guidelines, USFDA, EMA, MHRA, WHO, and other regulatory requirements.</li><li>Lead regulatory inspections, internal/external audits, and quality risk assessments.</li><li>Develop and enforce Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Quality Risk Management (QRM) processes.</li><li>Ensure timely handling of Out of Specification (OOS), Out of Trend (OOT), deviations, change controls, and CAPA implementation.</li><li>Collaborate with Regulatory Affairs to support dossier preparation, submission, and compliance with market-specific regulations.</li></ul>

Quality Assurance Head