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 prospects 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 Valuable 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.

📌 Agm Production Qms Bharuch (India)
🏢 SDP HR Solution
📍 India