Compounding Operator

Key Responsibilities: • Execute compounding and batch preparation processes for sterile oncology injectable formulations. • Perform CIP (Clean-in-Place) and SIP (Sterilization-in-Place) operations for mixing vessels and related equipment. • Conduct leak tests for compounding vessels, filters, and associated systems. • Operate and monitor VHP (Vaporized Hydrogen Peroxide) systems and isolators for sterile processing environments. • Carry out manual and visual inspection of vials for particulate matter, integrity, and clarity. • Handle raw material charging and maintain batch records, logbooks, and online documentation. • Ensure aseptic gowning and behavior as per Grade A/B area requirements. • Adhere to SOPs and manufacturing instructions (BMRs, BPRs) for each batch. • Coordinate with QA, QC, Engineering, and Validation teams for smooth production flow. • Identify and report any deviations, equipment malfunctions, or contamination risks. • Maintain a clean and safe working environment compliant with cGMP and EHS protocols. Required Skills & Experience: • Diploma/Bachelor s Degree in Pharmacy, Chemistry, or relevant science stream. • 2-5 years of experience in sterile injectable manufacturing, preferably in oncology. • Hands-on experience with CIP/SIP , vial inspection , isolators , and VHP systems . • Good understanding of cGMP , cleanroom classifications , and aseptic techniques . • Ability to follow strict protocols, documentation standards, and safety procedures.