- Prepare, review and control critical production documents for parenteral manufacturing, including BMRs, SOPs, logbooks, protocols and other related manufacturing records.

- Ensure compliance of production activities with cGMP, GDP, approved SOPs and established manufacturing procedures.

- Monitor and review shop-floor documentation and manufacturing records for completeness, accuracy and compliance with approved procedures.

- Lead and coordinate production-related incident and deviation investigations, including root-cause analysis using tools such as 5-Why and Fishbone; and ensure timely closure.

- Initiate, track and implement CAPA and Change Control activities related to production processes, equipment and documentation.

- Support Quality Risk Management activities related to manufacturing processes and identify opportunities for process and compliance improvement.





- Review production logbooks, online records and relevant audit trails to ensure proper documentation and traceability.

- Support preparation, review and execution of validation-related activities, including media fill documentation and protocols.

- Coordinate implementation of revised SOPs and procedures and provide training to production personnel on applicable GMP and documentation requirements.

- Support internal, customer and regulatory audits by providing required production records, QMS documentation and necessary shop-floor support.

- Maintain effective coordination with QA, Engineering, QC and other cross-functional teams for timely closure of production-related QMS activities.

📌 Process Incharge - Production (QMS) (Ahmedabad)
🏢 Otsuka Pharmaceutical
📍 Ahmedabad