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
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...
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.