Senior Executive - CQA

As a Quality Assurance Specialist, you will be responsible for ensuring GMP and GLP compliance through various audit activities at Loan Licence Units (LLU), Third Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs). Your key responsibilities will include: - Preparation and adherence to annual planner for Quality audits to monitor overall performance and compliance. - Reviewing audit compliance reports for external/regulatory/customer audits and ensuring timely closure of observations. - Conducting self-inspections, compiling reports, and tracking compliance for timely closure. - Coordinating technical document evaluation from vendors, arranging sample analysis, and maintaining records. - Introduction, implementation, and effectiveness checks for Quality Management System (QMS). - Presentation of monthly quality review meetings to highlight open issues and status. - Coordinating, tracking, and monitoring QMS, Vendor Management, and documentation activities. - Conducting training on important quality aspects and providing technical inputs to cross-functional teams. - Developing and implementing vendor qualification processes in line with quality standards. - Conducting risk assessments and due diligence for vendors. - Monitoring vendor performance through KPIs, scorecards, and audits. - Ensuring vendor compliance with quality, regulatory, and contractual requirements. - Planning, scheduling, and conducting internal and external quality audits. - Assessing vendor compliance with regulatory standards and internal SOPs. - Preparing audit plans, checklists, and reports with clear documentation. - Following up on audit findings, CAPA, and ensuring timely closure. - Driving quality improvement initiatives and recommending process improvements. - Providing training and guidance on quality and compliance expectations. - Maintaining audit records and ensuring data integrity and regulatory readiness. Skills required for this role include a deep understanding of ISO standards, GxP, GMP, FDA, ICH, and other regulatory frameworks, proficiency in implementing QMS frameworks, ability to investigate non-conformities, strong writing skills for audit reports and SOPs, ability to interpret audit trends and compliance metrics, strong problem-solving mindset, and effective communication skills across all organizational levels.,