Roles & responsibilities : -
Aseptic Setup & Operation: Operate and monitor sterile filling machines for ampules, vials, or cartridges located inside Restricted Access Barrier Systems (RABS) and Isolators. [1, 2]
Bio-Decontamination: Execute isolator sterilization cycles using Vaporized Hydrogen Peroxide (VHP) or similar agents before and after production batches. [, 2]
Glove Integrity & Environmental Control: Perform routine integrity tests on isolator gloves and closely monitor HEPA filter performance, positive pressure, and airflow metrics. [1, 2, 3]
Line Clearance & Change Parts: Conduct careful line clearance, formatting, and installation of change parts (filling needles, tubing) without breaking the sterile boundary. [1, 2, 3]
Documentation & Compliance: Complete real-time documentation, record batch data, and manage deviations strictly adhering to Valuable Manufacturing Practice (GMP) standards. [1, 2, 3, 4]
CIP/SIP Execution: Oversee Cleaning in Place (CIP) and Sterilization in Place (SIP) for fluid pathways and manufacturing vessels.

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

📌 Walk In Interviews For Staff / Technician Injectable Manufacturing Gujarat (India)
🏢 Intas
📍 India