Production Sterile - Aseptic - Sr. Executive
Job Description
? 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.