Production Manager

Exemed; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Exemed in Vadodara, India seeks a Production Operations leader to plan, organize, and monitor daily production activities to meet monthly and annual targets. You will ensure batch manufacturing aligns with approved BMRs and SOPs while optimizing planning to maximize equipment utilization and minimize downtime.

You will drive GMP and regulatory compliance, support audits, CAPA, and quality management, and lead EHS safety initiatives.

Qualifications

• Plan, organize, and monitor daily production activities to achieve monthly and annual production targets.
• Ensure timely execution of batch manufacturing as per approved Batch Manufacturing Records (BMRs) and SOPs.
• Coordinate with Planning, Warehouse, QA, QC, Engineering, EHS, and SCM for uninterrupted manufacturing.

Responsibilities

• Ensure production activities comply with quality standards.
• Review production documentation for completeness and accuracy.
• Investigare manufacturing deviations, OOS/OOT-related issues, and implement corrective actions.

Job description

Production Operations

• Plan, organize, and monitor daily production activities to achieve monthly and annual production targets.


• Ensure timely execution of batch manufacturing as per approved Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs).


• Optimize production planning to maximize equipment utilization and minimize downtime.


• Monitor batch yields, cycle times, and production efficiencies.


• Coordinate with Planning, Warehouse, QA, QC, Engineering, EHS, and SCM for uninterrupted manufacturing.

GMP & Regulatory Compliance

• Ensure strict adherence to cGMP, GLP, Data Integrity, and applicable regulatory requirements (USFDA, EU GMP, MHRA, WHO-GMP, etc.).


• Ensure compliance with approved SOPs, BMRs, validation protocols, and change control procedures.


• Support internal, customer, and regulatory audits.


• Implement CAPA arising from deviations, investigations, and audit observations.

Quality Management

• Ensure production activities comply with quality standards.


• Review production documentation for completeness and accuracy.


• Investigate manufacturing deviations, OOS/OOT-related production issues, and implement corrective actions.


• Support process validation, cleaning validation, and technology transfer activities.

Team Leadership

• Lead, mentor, and develop production executives, officers, supervisors, and operators.


• Conduct manpower planning and shift allocation.


• Identify training needs and ensure GMP and technical training compliance.


• Monitor team performance and implement continuous improvement initiatives.

Safety, Health & Environment (EHS)

• Ensure compliance with EHS policies and safe work practices.


• Promote a strong safety culture and ensure proper use of PPE.


• Participate in HAZOP, risk assessments, incident investigations, and emergency preparedness.


• Ensure safe handling of hazardous chemicals and solvents.

Continuous Improvement

• Reduce manufacturing costs through process optimization.


• Improve Overall Equipment Effectiveness (OEE).


• Minimize batch failures, deviations, solvent losses, and rework.

Documentation & Reporting

• Review and approve production records.


• Prepare daily, weekly, and monthly production reports.


• Monitor production KPIs and present performance to management.


• Maintain documentation readiness for regulatory inspections.

Cross-Functional Coordination

• Coordinate with QA for batch release activities.


• Work closely with QC for timely testing.


• Coordinate with Engineering for preventive maintenance and breakdown management.


• Coordinate with Warehouse for material availability.


• Support new product scale-up and commercial manufacturing.