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 Positive 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 solid quality culture throughout the organization and continuously identify prospects 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

📌 Qa Manager Balussery
🏢 LifeInfusion Pharmaceuticals PvtLtd.,
📍 Balussery