Executive – Corporate Quality Assurance

About the role

We are seeking a dynamic Executive / Senior Executive in Corporate Quality Assurance to strengthen our corporate quality function. The role will drive Quality Management Systems across manufacturing sites, ensure regulatory compliance, support audit readiness and promote harmonised quality practices.

Key responsibilities

• Drive harmonisation and implementation of QMS across manufacturing sites.
• Prepare, review and implement SOPs for QMS, validation, qualification, change control, CAPA and training management.
• Conduct and coordinate periodic self‑inspections/internal audits and ensure timely closure of observations.
• Manage market complaints, product recall activities and associated investigations.
• Review and monitor change controls, deviations, OOS/OOT, CAPAs and other quality system elements.
• Ensure robust investigation practices, root‑cause analysis and CAPA implementation across sites.
• Coordinate with manufacturing, R&D, regulatory affairs and other cross‑functional teams for new product development and technology transfer.
• Support implementation and management of SAP, ERP, eQMS and other digital quality systems.
• Manage GMP and quality training programmes, conduct training sessions and ensure compliance.
• Lead regulatory inspections, customer audits and internal audits while maintaining continuous audit readiness.

Required profile

• B.Pharm / M.Pharm / M.Sc. in Chemistry, Microbiology, Biotechnology or Life Sciences.
• 5‑10 years of experience in corporate quality assurance or quality systems within the pharmaceutical industry.
• Experience with regulated markets such as USFDA, EU GMP, MHRA, WHO‑GMP or PIC/S (preferred).
• Strong knowledge of cGMP, GDP, ICH guidelines and data integrity.
• Hands‑on experience with CAPA, change control, deviations, OOS/OOT, risk management, validation and documentation.
• Experience handling regulatory inspections and customer audits.
• Familiarity with SAP, ERP or eQMS quality management systems.

Required skills

• cGMP
• GDP
• ICH guidelines
• Data integrity
• CAPA management
• Change control
• Deviation handling
• OOS/OOT investigation
• Risk management
• Validation
• Documentation control
• SAP
• ERP
• eQMS