Production Trainee

Regenix Biosciences Limited; Chennai District; Sur place; INR 300 000 - 540 000; Plein temps

Résumé du poste

Regenix Biosciences Limited in Chennai, Tamil Nadu, is seeking a production professional to execute pharmaceutical and insulin manufacturing according to SOPs, BMRs and GMP. The role involves handling production operations, monitoring processes, and ensuring strict adherence to safety, hygiene and documentation standards.

You will monitor critical process parameters, ensure equipment readiness, manage line clearances and changeovers, and maintain thorough records.

Responsabilités

• Responsible for executing pharmaceutical and insulin manufacturing activities as per approved SOPs, Batch Manufacturing Records (BMRs), and GMP guidelines.
• Handling production operations, process monitoring, and batch execution as per approved manufacturing procedures.
• Ensuring compliance with cGMP, data integrity, safety, hygiene, and documentation requirements.
• Monitoring critical process parameters, in-process controls, batch yield, and production performance.
• Ensuring equipment readiness, line clearance, cleaning, and changeover activities before manufacturing operations.
• Maintaining accurate and timely documentation, including BMRs, equipment logbooks, cleaning records, and production reports.
• Coordinating with QA, QC, Engineering, Warehouse, and Maintenance departments for smooth production activities.
• Ensuring adherence to contamination control practices, gowning procedures, and aseptic practices, wherever applicable.
• Reporting deviations, equipment breakdowns, and process abnormalities, and supporting investigations and CAPA implementation.
• Monitoring production schedules, manpower utilization, material consumption, and batch completion timelines.
• Supporting internal audits, regulatory inspections, validation activities, and continuous improvement initiatives.
• Ensuring safe handling of materials, proper housekeeping, and compliance with applicable pharmaceutical regulatory requirements.

Description du poste

• Responsible for executing pharmaceutical and insulin manufacturing activities as per approved SOPs, Batch Manufacturing Records (BMRs), and GMP guidelines.
• Handling production operations, process monitoring, and batch execution as per approved manufacturing procedures.
• Ensuring compliance with cGMP, data integrity, safety, hygiene, and documentation requirements.
• Monitoring critical process parameters, in-process controls, batch yield, and production performance.
• Ensuring equipment readiness, line clearance, cleaning, and changeover activities before manufacturing operations.
• Maintaining accurate and timely documentation, including BMRs, equipment logbooks, cleaning records, and production reports.
• Coordinating with QA, QC, Engineering, Warehouse, and Maintenance departments for smooth production activities.
• Ensuring adherence to contamination control practices, gowning procedures, and aseptic practices, wherever applicable.
• Reporting deviations, equipment breakdowns, and process abnormalities, and supporting investigations and CAPA implementation.
• Monitoring production schedules, manpower utilization, material consumption, and batch completion timelines.
• Supporting internal audits, regulatory inspections, validation activities, and continuous improvement initiatives.
• Ensuring safe handling of materials, proper housekeeping, and compliance with applicable pharmaceutical regulatory requirements.