Production Executive-API

Sarthee Consultancy; Pune District; On-site; INR 300,000 - 380,000; Full time

Job summary

Sarthee Consultancy is seeking a Production Operations/Quality & Compliance professional in Pune, Maharashtra. The role focuses on executing daily production activities, ensuring GMP-compliant operations, and supporting batch completion with quality standards.

The candidate will maintain GMP documentation, handle deviations and CAPA, coordinate with QA, QC, Engineering, and Warehouse, and assist in training operators on SOPs and safety practices on the shop floor.

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.

Job description

Role & responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.