Key Responsibilities:
* Developing Comprehensive Contamination Control Strategies, aligning with Annex I and global GMP guidelines to ensure product quality.
Job Description
The Sterility Assurance Specialist plays a critical role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies. This expert ensures that all processes are designed to minimize contamination risk, from raw material receipt to finished product shipment.
Oversight of Environmental Monitoring -----------------------------------
• Manage environmental monitoring programs effectively supporting a septic manufacturing operations .• The specialist must be well-versed in regulatory requirements for sterile products, including Annex I guidance on sterilization practices.