Quality Analyst

JOB DESCRIPTION EXECUTIVE AND ABOVE

Job Purpose

To lead and maintain the Pharmaceutical Quality Management System (QMS) and ensure compliance with cGMP and applicable regulatory requirements, while driving continual improvement and maintaining product quality and patient safety.

Key Responsibilities – QMS

• Establish, implement and maintain an effective Pharmaceutical QMS across the site.
• Ensure compliance with GMP, company procedures, quality policies and regulatory requirements.
• Ensure effective control and periodic review of SOPs, specifications, BMR/BPR, MFR and other controlled documents.
• Review and approve deviations, investigations, OOS/OOT, CAPA and change controls and ensure timely closure and effectiveness.
• Ensure implementation of Quality Risk Management (QRM) principles for quality-related activities.
• Monitor quality trends, recurring deviations, complaints and process performance and initiate appropriate improvements.
• Ensure timely preparation and review of APQR/PQR and stability-related activities.
• Lead self-inspections, regulatory/customer audits and ensure effective implementation and closure of audit CAPA.
• Ensure appropriate training, qualification and competency of personnel involved in GMP activities.
• Ensure effective management of market complaints, product returns and recalls.
• Ensure vendor qualification, vendor audits and supplier quality management.
• Conduct/coordinate Management Review Meetings and report QMS performance and significant quality risks to management.
• Ensure continual improvement of the QMS through CAPA, risk assessment, trend analysis and quality improvement initiatives.
• Maintain inspection readiness and ensure timely implementation of regulatory commitments.