Role & responsibilities: -

: 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.

: 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

📌 Walk-in Interview For Injectable Manufacturing` (Ahmedabad)
🏢 Intas
📍 Ahmedabad