Senior Executive - Quality Assurance

Role Overview and Responsibilities

• Manage daily AQA/IPQA operations within manufacturing and packaging units.
• Conduct line clearance protocols and verify manufacturing and packing procedures.
• Examine Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and associated batch documentation.
• Ensure compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and quality protocols.
• Oversee manufacturing operations to detect quality and GMP violations.
• Lead and assist investigations of deviations, incidents, Out-Of-Specification (OOS)/Out-Of-Trend (OOT) results, and customer complaints.
• Develop, execute, and monitor Corrective and Preventive Actions (CAPA) and Change Control processes.
• Support validation activities including process validation, cleaning validation, and qualification tasks.
• Assess and review QA-related SOPs, protocols, reports, and records for accuracy and compliance.
• Engage in internal, customer, and regulatory audits, ensuring timely resolution of audit findings and compliance measures.
• Deliver GMP awareness and documentation training to plant staff members.
• Collaborate interdepartmentally with Production, Quality Control (QC), Warehouse, and Engineering teams.
• Maintain thorough documentation practices and uphold data integrity within all QA activities.
• Drive continuous enhancement of the Quality Management System (QMS).

Preferred Candidate Profile

• Possession of B.Pharm, M.Pharm, B.Sc, or M.Sc degree with 4-8 years of relevant Quality Assurance experience.
• Background in pharmaceutical, cosmetic, personal care, or other regulated manufacturing industries is advantageous.
• Proven practical experience in AQA/IPQA duties, GMP adherence, line clearance procedures, and comprehensive batch documentation review.
• Strong familiarity with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Quality Management Systems (QMS).
• Hands-on knowledge of managing deviations, CAPA, Change Control, OOS/OOT, risk assessments, and investigative processes.
• Experience with process and cleaning validation as well as equipment qualification is a distinct plus.
• Excellent grasp of SOP compliance, batch record management, audit readiness, and data integrity principles.
• Effective documentation, analytical skills, communication proficiency, and coordination abilities.
• Capability to collaborate efficiently with cross-functional teams including Production, QC, Warehouse, and Engineering.
• Preference given to candidates able to autonomously manage shop-floor QA operations and sustain compliance standards.