We are looking for an experienced Sr. Executive – QC (QMS) to ensure effective implementation and compliance of Quality Management Systems, regulatory requirements, documentation, audits, validation and quality processes within the organization.
Key Responsibilities
- Ensure compliance with QMS, GMP, GLP and WHO-GMP requirements.
- Prepare, review and maintain QMS documentation and regulatory dossiers.
- Ensure ALCOA+ principles are followed in all quality-related documentation and records.
- Handle deviations, investigations, Root Cause Analysis (RCA) and CAPA.
- Conduct and support internal audits and regulatory inspections.
- Manage calibration activities and related documentation.
- Handle Analytical Method Validation (AMV) and other validation activities.
- Prepare and review APQR/PQR documentation.
- Support food safety and quality compliance requirements.
- Handle product recall procedures and related documentation.
- Ensure proper documentation, data integrity and compliance with applicable quality standards.
- Coordinate with QC, R&D;, Production and other departments for QMS-related activities.