:

- 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 Positive 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)
🏢 SDP HR Solution
📍 Bharuch