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.