Job Overview
Required Skills
Job Description
We are looking for an experienced Senior Executive – QA/QC QMS to support and maintain the Quality Management System of a pharmaceutical manufacturing facility.
Key Responsibilities:
• Ensure implementation and compliance of QMS requirements.
• Maintain GMP, GLP and applicable quality-system requirements.
• Prepare and review QMS documentation.
• Handle deviations, investigations, RCA and CAPA.
• Manage change-control activities.
• Support internal audits and regulatory inspections.
• Coordinate calibration and validation documentation.
• Support Analytical Method Validation activities where applicable.
• Prepare/review APQR/PQR documentation.
• Ensure ALCOA+ and data-integrity principles are followed.
• Coordinate with QA, QC, Production and R&D.
• Support product quality investigations and recall-related documentation.
• Monitor compliance with approved procedures.
• Train relevant personnel on quality-system requirements.
Preferred Experience:
• 4–8 years of relevant QA/QC/QMS experience.
• Pharmaceutical manufacturing experience preferred.
• Strong knowledge of GMP/GLP and quality documentation required.
• Experience in audits, CAPA, deviation, RCA and change control preferred.