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Compounding Operator
We're Hiring: Compounding Operator
We are seeking a skilled and detail-oriented Compounding Operator to join our oncology injectables manufacturing unit. The role involves preparation of sterile injectable products through strict adherence to cGMP guidelines, maintaining aseptic techniques, and ensuring equipment and environment compliance.
- Location: Shameerpet
- Department: Manufacturing – Injectables
- Qualification: M.Pharm, B.Pharm, B.Tech, Diploma, ITI
- Experience: 2 to 5 Years (preferably in oncology manufacturing)
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.