AGM - Production (QMS)

Job Description:

• Lead Production-related QMS activities including SOPs, Deviations, CAPA, Change Control, and Risk Management.
• Lead OOS/OOT investigations with QA/QC and provide technical inputs.
• Review batch records, process parameters, equipment, materials, and manufacturing history.
• Drive root cause analysis, impact assessment, and scientifically justified conclusions.
• Lead investigations for deviations, process failures, batch discrepancies, yield variations, and equipment issues.
• Implement and monitor Production CAPA and ensure timely effectiveness checks.
• Apply investigation tools such as 5-Why, Fishbone, FMEA, and risk assessment.
• Monitor QMS trends and identify opportunities for process and quality improvement.
• Ensure timely closure of Production actions arising from investigations, audits, and QMS activities.
• Support regulatory, customer, corporate, and internal audits and ensure inspection readiness.
• Ensure compliance with cGMP, approved manufacturing processes, validated parameters, SOPs, and safety requirements.
• Drive Good Documentation Practices (GDP) and data integrity across Production operations.
• Ensure proper documentation, review, and compliance of manufacturing records.
• Drive continuous improvement and prevent recurrence of quality and process-related issues.