Roles & Responsibilities
- Oversee and manage the Quality Assurance department and ensure compliance with applicable GMP, GLP, WHO-GMP, Schedule M, and regulatory requirements.
- Establish, implement, and maintain the company’s Quality Management System (QMS).
- Review and approve SOPs, specifications, protocols, batch manufacturing records, batch packing records, and other quality documents.
- Ensure effective implementation of Good Documentation Practices (GDP) and data integrity requirements.
- Review and approve deviations, non-conformances, OOS/OOT investigations, CAPA, change controls, and risk assessments.
- Ensure proper batch record review and release/rejection in accordance with approved procedures.
- Coordinate and oversee internal audits, self-inspections, vendor audits, and regulatory inspections.
- Monitor compliance of production, QC, warehouse, engineering, and other departments with approved quality procedures.
- Ensure proper handling of market complaints, product recalls, product quality reviews, and quality-related investigations.
- Review and approve validation and qualification documents, including process validation, cleaning validation, equipment qualification, and analytical method validation where applicable.
- Ensure proper training and competency assessment of QA personnel and relevant employees on GMP and quality procedures.
- Monitor environmental and hygiene requirements and ensure appropriate sanitation and contamination-control practices.
- Coordinate with QC, Production, Engineering, Warehouse, and Regulatory Affairs to resolve quality-related issues.
- Prepare and review quality reports, trend analysis, KPIs, and management review inputs.
- Ensure timely closure of CAPA, deviations, audit observations, and other quality-system actions.
- Promote a strong quality culture throughout the organization and continuously identify opportunities for quality-system improvement.
- Perform any other quality-related duties and responsibilities assigned by management.
Pay: ₹15,000.00 - ₹50,000.00 per month
Work Location: In person
