Senior Executive Quality

Role Overview: You will be designated as a Senior Executive - Quality (Audit and compliance) in the Corporate Quality department at Shalina Healthcare. Your main responsibility will be to conduct Vendor Quality Audits and ensure GMP and GLP compliance at various manufacturing and testing facilities. You will also be involved in preparing and presenting quality review meetings, conducting self-inspections, and coordinating with cross-functional teams for maintaining the quality system. Key Responsibilities: - Prepare and adhere to annual planner for Quality audits for Loan licence Units (LLU), Third Party Manufacturing Sites, public testing laboratories, and Shalina Operating units (OUs) - Review audit compliance reports for external/regulatory/customer audits and monitor closure of observations - Conduct self-inspections, compile reports, and track compliance for timely closure - Ensure all-time audit readiness of manufacturing sites - Coordinate for compilation and review of technical documents from vendors, conduct sample analysis, and maintain technical records - Introduce, implement, and check effectiveness of Quality Management System (QMS) - Prepare for monthly quality review meetings, highlight unresolved issues, and provide technical inputs to cross-functional teams - Develop and implement vendor qualifications and onboarding processes - Conduct risk assessments, due diligence, and audits for new and existing vendors - Monitor vendor performance through KPIs, scorecards, and reviews - Ensure vendor compliance with quality, regulatory, and contractual requirements - Plan, schedule, and conduct internal and external quality audits, including vendor audits - Assess vendor compliance with regulatory standards and internal SOPs - Prepare audit plans, checklists, and reports with clear documentation of observations and non-conformities - Drive quality improvement initiatives and recommend process improvements based on audit trends - Provide training and guidance on quality and compliance expectations - Maintain audit records and ensure data integrity and regulatory readiness Qualification Required: - M Pharmacy / B Pharmacy - Deep understanding of ISO, GxP, GMP, FDA, ICH, or other applicable regulatory frameworks - Proficient in implementing, auditing, and maintaining QMS frameworks - Strong problem-solving skills and ability to interpret audit trends and compliance metrics - Excellent communication skills and ability to effectively communicate audit findings across all organizational levels,