Production Executive-API

Sarthee Consultancy; Bengaluru; On-site; INR 350,000 - 550,000; Full time

Job summary

Sarthee Consultancy in Bengaluru seeks a Production Operations & Execution professional to manage day-to-day production activities as per the plan, ensuring equipment and process compliance with SOPs and GMP guidelines. You will monitor batches, optimize efficiency, and minimize downtime while maintaining accurate BPR records and supporting audit readiness.

You will coordinate with QA, QC, Engineering, and Stores, ensuring material availability and timely reporting.

Qualifications

• Maintain Batch Production Records (BPR) and GMP documents accurately.
• Follow SOPs and GMP practices on the shop floor to ensure compliance.
• Support audit readiness through complete, error-free documentation.
• Assist in documenting deviations, CAPA, and root cause analysis.
• Report non-conformances or process abnormalities to seniors for corrective action.
• Coordinate with QA, QC, Engineering, and Warehouse as required.
• Ensure availability of raw materials and packing materials before batch initiation.
• Support data preparation for production planning and reporting.

Responsibilities

• Execute day-to-day production activities per the production plan and schedule.
• Ensure smooth operation of equipment and processes in line with SOPs and GMP guidelines.
• Monitor batch processes to meet required quality standards and timelines.
• Assist in optimizing production efficiency and minimizing downtime.
• Maintain and update GMP documents and BPR records accurately.
• Support audit readiness with complete, error-free documentation.
• Handle deviations, CAPA, and root cause analysis when needed.
• Report non-conformances and process abnormalities to seniors.
• Assist in OOS/OOT investigations and corrective actions.
• Ensure RM/PM availability and coordinate with stores for timely material access.
• Prepare data for production planning and reporting.
• Adhere to safety and GMP practices on the shop floor.
• Coordinate with cross-functional teams for seamless operations.
• Assist in on-the-job training of operators and junior staff.

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.