Key Skills Required:

Autoclave Operator , Autoclave Supervisor, Manufacturing Operator , Manufacturing Supervisor, Vial Washing & Tunnel Operator, Vial Washing & Tunnel Supervisor, Filling Operator, Filling Supervisor, Lyo Operator, Lyo Supervisor, Packing Operator, Packing Supervisor, QMS, Garment Washing , House Keeping

- Prepare autoclave loads as per approved validated load patterns, operate autoclaves and sterilization equipment, and ensure all sterilization cycles are executed, monitored, and documented accurately in accordance with approved procedures and records.
- Perform operation, cleaning, maintenance, routine checks, filter integrity testing, and support qualification activities such as OQ, PQ, and media fill validations.
- Maintain accurate records, logs, checklists, and sterilization documentation while ensuring compliance with GMP, GDP & data integrity requirements, and regulatory standards.

Coordinate with QA for line clearance, report deviations and incidents, follow cleanroom gowning and hygiene practices, and prevent contamination through adherence to SOPs and participate in continuous improvement initiatives for safety, compliance, and operational efficiency.

- Supervise and coordinate daily sterilization activities, ensure autoclave loads are prepared as per validated load patterns, assign work responsibilities, monitor team performance, and ensure all sterilization cycles are executed in compliance with approved BMRs, SOPs, and validated parameters.
- Review and verify sterilization records, equipment logbooks, checklists, and process documentation for completeness and accuracy as per approved procedures; ensure compliance with GMP, GDP, Data Integrity and regulatory requirements.
- Supervise the autoclave operation, filter integrity testing, routine equipment inspections, preventive maintenance activities, and support qualification and validation studies including IQ/OQ/PQ, media fills, and requalification activities.





- Manufacturing and sterile compounding activities as per approved BMRs and SOPs, operate the Manufacturing (Mixing) Vessel and Compounding Isolator, and ensure accurate dispensing, transfer, and addition of materials under aseptic conditions.
- Perform pre-use equipment checks, line clearance, isolator leak testing, glove integrity testing, load cell verification, vent filter integrity testing, and ensure equipment calibration and readiness prior to batch execution.

- Supervise and coordinate sterile compounding and manufacturing activities, ensuring operation of the Manufacturing Vessel and Compounding Isolator in compliance with approved BMRs, SOPs, validated processes, and regulatory requirements.
- Ensure completion and review of pre-use checks, line clearance, isolator leak tests, glove integrity tests, load cell verification, vent filter integrity testing, equipment calibration activities, and support qualification and validation studies including IQ, OQ, PQ, requalification, and media fills.
- Review and verify batch documentation, equipment logbooks, calibration records, filter integrity test records, and critical process parameters to ensure compliance with GMP, GDP, data integrity requirements, and approved procedures.

- Monitor critical process parameters during vial washing and depyrogenation tunnel operation and automatic vial transfer to ensure compliance with validated washing and Depyrogenation requirements.
- Perform cleaning and sanitization of equipment as per validated procedures, maintain accurate GMP documentation and records, and ensure compliance with GMP,



GDP, data integrity and regulatory requirements.

Report equipment alarms, SCADA abnormalities, temperature excursions, filter integrity failures, and other non-conformities promptly; coordinate with IPQA and Engineering teams, maintain GMP and cleanroom practices

- Supervise and coordinate vial washing and Depyrogenation activities, ensuring operation of the Vial Washing Machine and Depyrogenation Tunnel in compliance with approved BMRs, SOPs, validated process parameters.
- Ensure completion and review of pre-use checks, line clearance activities, equipment readiness, utility availability, SCADA verification, filter integrity testing, and monitoring of critical process parameters during vial washing and depyrogenation tunnel operations.
- Review and verify batch records, equipment logbooks, washing records, temperature records, filter integrity reports, and cleaning documentation in-line with approved procedures to ensure compliance with GMP, GDP, data integrity requirements

- Execute aseptic filling activities as per approved BMRs, SOPs, and validated process parameters, including operation of the Filling Machine, ALUS, Capping Machine and Filling Isolator.
- Perform and document batch preparatory activities including Wash Cycle, Isolator Leak Test, VHP Cycle, SIP Cycle, Filter Integrity Testing (FIT), Glove Leak Testing, verification of sterilized materials, and confirmation of system readiness prior to batch initiation.

Operation of online Non-Viable Particle Monitoring

- Supervise and coordinate aseptic filling activities, ensuring filling operations are executed in compliance with approved BMRs, SOPs, validated process parameters.
- Ensure completion and review of all batch activities including Wash Cycle, Isolator Leak Test, VHP Cycle, SIP Cycle, Filter Integrity Testing (FIT), Glove Leak Testing, CIP activities, SCADA verification.

📌 Operator/Supervisor (Thiruvallur)
🏢 Caplin Point
📍 Thiruvallur