Role & responsibilities: -

Job Description: Diploma / ITI (Operator / Technician)
Role Focus: Machine operation, cleaning, sterilization, and physical execution of the sterile process. [1, 2]
Key Responsibilities:
Operate and monitor cleanroom equipment like vial/ampoule washing machines, sterilizing tunnels, autoclaves, and compounding vessels.
Perform Clean-In-Place (CIP) and Sterilize-In-Place (SIP) activities for manufacturing tanks and filling lines.
Handle aseptic gowning procedures and maintain cleanroom hygiene (temperature, humidity, and pressure monitoring).
Assist in equipment setup, basic mechanical troubleshooting, and routine changeovers.
Record basic operational parameters in logbooks and machine usage sheets.

Job Description: Degree Holder - B.Pharm / B.Sc / M.Pharm / M.Sc (Officer / Executive)
Role Focus: Batch processing management, regulatory compliance, critical documentation, and quality assurance coordination. [1]
Key Responsibilities:




Execute and monitor complex aseptic processing steps like compounding, solution filtration, and sterile filling/sealing.
Complete and review Batch Manufacturing Records (BMR) and Batch Production Records (BPR) in compliance with cGMP.
Perform line clearance, in-process quality checks, and filter integrity tests (bubble point test).
Coordinate with Quality Assurance (QA) and Quality Control (QC) for environmental monitoring and product sampling.
Oversee junior operators and ensure adherence to Standard Operating Procedures (SOPs) and safety rules during the shift.
Support regulatory audits (USFDA, MHRA, WHO) by maintaining floor readiness and complete traceability documentation.

Preferred candidate profile: -
Required Experience: - 3 to 12 Years
Required Qualification: - M.Pharm. / B. Pharm. / Diploma / ITI

Regards,

Human Resources Department

Intas Pharmaceuticals SEZ Plant

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