Key Responsibilities

QMS & Documentation

- Ensure timely preparation, review and execution of all production-related GMP documentation.
- Handle issuance, retrieval, reconciliation and archival of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), logbooks and production formats.
- Prepare, review and update SOPs, Formats, Protocols and Work Instructions as per the document control system.
- Maintain department documentation in compliance with cGMP, GDP and Data Integrity requirements.
- Ensure timely closure of documentation observations and compliance gaps.

Quality Management System

- Coordinate and monitor Deviations, Change Controls, CAPA and Incident investigations related to Production.
- Perform root cause analysis and support implementation of effective CAPA.
- Track QMS timelines and ensure timely closure in coordination with QA and cross-functional departments.
- Support Risk Assessment activities and implementation of quality improvement initiatives.

Production Compliance

- Ensure all production activities are performed in accordance with approved SOPs and cGMP guidelines.
- Monitor documentation practices on the shop floor and ensure Good Documentation Practices (GDP).
- Ensure compliance with regulatory requirements including Schedule M, WHO-GMP and applicable internal quality standards.
- Coordinate with QA during line clearance, batch release documentation and routine compliance activities.

Audit & Inspection

- Coordinate and support Internal Audits, Self-Inspections, Customer Audits and Regulatory Audits.
- Prepare responses for audit observations and ensure timely implementation of corrective and preventive actions.
- Maintain audit readiness of the Production Department at all times.

Training

- Conduct and coordinate departmental GMP, SOP and QMS-related training.




- Maintain training records and ensure employee qualification compliance.
- Promote quality culture and GMP awareness among production personnel.

Production Coordination

- Coordinate with Production, QA, QC, Warehouse, Engineering and EHS departments for smooth execution of QMS activities.
- Support production planning by ensuring documentation readiness before batch initiation.
- Assist shift teams in resolving documentation and compliance-related issues.

System & SAP Activities

- Perform SAP transactions related to production documentation, material movements and batch status as applicable.
- Maintain departmental trackers and prepare daily, weekly and monthly MIS reports.
- Monitor pending QMS activities and submit periodic compliance reports to department management.

Required Skills

- Solid knowledge of cGMP, GDP and Data Integrity principles.
- Hands-on experience in Deviations, CAPA, Change Control and Incident Management.
- Sound understanding of Batch Manufacturing Documentation.
- Experience in SOP preparation, review and document control.
- Working knowledge of SAP (Production Module preferred).
- Good understanding of regulatory requirements such as WHO-GMP and Schedule M.
- Excellent documentation, analytical and problem-solving skills.
- Strong communication and cross-functional coordination abilities.
- Proficiency in Microsoft Excel, Word and PowerPoint.

Preferred Experience

- Experience in API, Pharmaceutical or Life Science manufacturing.
- Exposure to Internal, Customer and Regulatory Audits.
- Experience handling QMS activities independently within the Production Department.

Key Competencies

- Quality & Compliance Orientation
- Attention to Detail
- Documentation Excellence
- Analytical Thinking
- Planning & Organizing
- Team Coordination
- Decision Making
- Ownership & Accountability
- Continuous Improvement
- Effective Communication

📌 Senior Production Executive (Vadodara)
🏢 BDR Pharmaceuticals
📍 Vadodara