Job Purpose

Lead the Quality Assurance function for Sterile Manufacturing by ensuring compliance with cGMP, regulatory requirements, Quality Management Systems (QMS), and quality standards while driving continuous improvement and audit readiness.

Key Responsibilities

• Lead and maintain the Quality Management System (QMS) across the plant.
• Ensure compliance with cGMP, regulatory guidelines, SOPs, and data integrity requirements.
• Review and approve quality documents, validation protocols/reports, BMR/BPR, PQR/APR, stability data, and master documents.
• Approve batch disposition and release finished products.
• Lead investigations related to deviations, OOS/OOT, complaints, recalls, and ensure effective CAPA implementation.
• Review and approve Technology Transfer documents and oversee new product introductions.
• Monitor validation, qualification, calibration, and preventive mai...