Production Sterile Aseptic Sr. Executive
Job Summary
Sterile Manufacturing Operations: Overseeaseptic filling compounding filtration and lyophilization processes to ensure product sterility and quality.
Aseptic Practices & Compliance: Ensure adherence toGMP USFDA MHRA WHO and EU-GMP guidelines maintaining sterility assurance in cleanroom environments.
Process Monitoring & Validation: Perform in-process checks review batch records and supportmedia fill validation sterility testing and equipment qualification.
Documentation & Batch Records: MaintainBMR/BPR deviation reports and compliance documentation as per regulatory standards.
Troubleshooting & Process Improvement: Identify and resolvemanufacturing deviations aseptic failures and process inefficiencies to ensure continuous improvement.
Coordination & Training: Work closely with QA QC and Engineering teams and train staff on sterile handling gowning and aseptic techniques.
Required Experience:
Senior Exec