Job Title: Sterility Assurance Lead
The Sterility Assurance Lead plays a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies.
This role extends beyond microbiological testing to encompass comprehensive oversight of aseptic manufacturing, contamination risk management, and adherence to global regulatory requirements.
It involves close collaboration across departments to drive sterility assurance initiatives while fostering a culture of quality excellence.
* Developing and implementing comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.
* Conducting risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
* Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
Oversight of Environmental Monitoring and Contamination Control:
* Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
* Investigating out-of-specification results in environmental monitoring, identifying root causes, and implementing corrective actions to prevent recurrence.
* Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices.
Support for Sterility-Related Validations and Audits:
* Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during report reviews and approvals.
* Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness.
* Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions.
Leadership and Collaboration:
* Leading a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles.
* Working cross-functionally with Quality, Manufacturing, and Engineering teams to ensure alignment on sterility assurance requirements.
* Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.
Documentation and Reporting:
* Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports.
* Tracking and reporting sterility assurance performance metrics to identify areas for improvement and enhance contamination control strategies.
Instrument and System Management:
* Supporting the qualification of isolators and other equipment within the laboratory.