Role &

responsibilities: -
Aseptic Operations: Operate high-speed sterile filling, sealing, and washing lines (vials, ampoules, or pre-filled syringes) within Grade A/B cleanroom settings.
Equipment Monitoring: Control and adjust critical process parametersincluding filling volumes, line speeds, and pressure differentialsto ensure optimal machine performance.
Sterilization Processes: Execute Clean-in-Place (CIP) and Sterilize-in-Place (SIP) protocols for all formulation and filling equipment, including the operation of autoclaves and depyrogenation tunnels.
cGMP Documentation: Complete Batch Manufacturing Records (BMR), logbooks, and line clearance checklists in real-time compliance with USFDA, MHRA, and WHO-GMP standards.
Setup & Changeovers: Perform productive machine setups, line clearances, and component changeovers between different product batches to minimize downtime.




Troubleshooting & Maintenance: Address minor mechanical breakdowns independently and assist the engineering team with preventive maintenance and equipment validation.
Contamination Control: Strictly adhere to advanced aseptic gowning protocols and cleanroom behavioral guidelines to eliminate any risk of cross-contamination.
Cross-Functional Teamwork: Coordinate closely with Quality Assurance (QA) for environmental monitoring samples and inline optical inspection protocols.

Preferred candidate profile: -
Required Experience: - 3 to 8 Years
Required Educational Qualification: - B. Pharma / Diploma / ITI

Regards,

Human Resources Department

Intas Pharmaceuticals SEZ Plant

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