Production Executive-API

Sarthee Consultancy; India; On-site; INR 450,000 - 650,000; Full time

Job summary

Sarthee Consultancy in India is seeking a Production Operations & Execution professional to manage day-to-day production activities and ensure compliance with SOPs and GMP guidelines. You will monitor batch processes, optimize efficiency, and maintain quality standards.

You will also maintain Batch Production Records, support audits, coordinate with QA/QC/Engineering/Warehouse, and train junior staff while ensuring safety and regulatory adherence on the shop floor.

Qualifications

• Experience in production operations with GMP/regulatory awareness.
• Ability to maintain GMP-compliant documentation and records.
• Strong coordination with QA, QC, Engineering and Warehouse.

Responsibilities

• Execute day-to-day production activities as per the production plan and schedule.
• Ensure smooth operation of equipment and processes in compliance with SOPs and GMP guidelines.
• Monitor batch processes and ensure timely completion with required quality standards.
• Assist in optimizing production efficiency and minimizing downtime.
• Maintain and update Batch Production Records (BPR) and other GMP documents accurately.
• Ensure proper documentation practices in line with regulatory requirements.
• Support audit preparedness by maintaining complete and error-free documentation.
• Assist in handling deviations, change controls, CAPA, and root cause analysis.
• Report any non-conformance or process abnormalities to seniors.
• Support OOS/OOT investigations and implementation of corrective actions.
• Ensure availability of raw materials (RM), packing materials (PM), and required documents before batch initiation.
• Coordinate with stores and procurement teams for timely material availability.
• Support data preparation for production planning and reporting.
• Follow SOPs and ensure adherence to safety and GMP practices on the shop floor.
• Coordinate with cross-functional teams like QA, QC, Engineering, and Warehouse.
• Assist in on-the-job training of operators and junior staff.

Skills

Production planning

GMP compliance

SOP adherence

Quality control

Cross-functional coordination

Documentation

Audit support

Training others

Job description

Role & responsibilities:

Production Operations & Execution

• Execute day-to-day production activities as per the production plan and schedule.
• Ensure smooth operation of equipment and processes in compliance with SOPs and GMP guidelines.
• Monitor batch processes and ensure timely completion with required quality standards.
• Assist in optimizing production efficiency and minimizing downtime.

Documentation & Compliance

• Maintain and update Batch Production Records (BPR) and other GMP documents accurately.
• Ensure proper documentation practices in line with regulatory requirements.
• Support audit preparedness by maintaining complete and error-free documentation.

Quality Systems & Process Support

• Assist in handling deviations, change controls, CAPA, and root cause analysis.
• Report any non-conformance or process abnormalities to seniors.
• Support OOS/OOT investigations and implementation of corrective actions.

Material & Resource Coordination

• Ensure availability of raw materials (RM), packing materials (PM), and required documents before batch initiation.
• Coordinate with stores and procurement teams for timely material availability.
• Support data preparation for production planning and reporting.

Training & Coordination

• Follow SOPs and ensure adherence to safety and GMP practices on the shop floor.
• Coordinate with cross-functional teams like QA, QC, Engineering, and Warehouse.
• Assist in on-the-job training of operators and junior staff.