Production Sterile Senior Executive
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Job Summary
Sterile Manufacturing Operations: Oversee aseptic filling compounding filtration and lyophilization processes to ensure product sterility and quality.
Aseptic Practices & Compliance: Ensure adherence to GMP USFDA MHRA WHO and EU-GMP guidelines maintaining sterility assurance in cleanroom environments.
Process Monitoring & Validation: Perform in-process checks review batch records and support media fill validation sterility testing and equipment qualification.
Documentation & Batch Records: Maintain BMR/BPR deviation reports and compliance documentation as per regulatory standards.
Troubleshooting & Process Improvement: Identify and resolve manufacturing 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 IC
Key Skills
- Category Management
- Corporate Paralegal
- Access Control System
- Ftp
- Channel Sales
- IT System Administration
