Job Title: Sterility Assurance Lead
This is a pivotal role in ensuring the sterility of injectable products through robust contamination control and sterility assurance strategies.
* Key Responsibilities
o Developing and implementing comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines.
o Conducting risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
o Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
o Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks.
o Investigating out-of-specification results in environmental monitoring, identifying root causes, and implementing corrective actions to prevent recurrence.
o Oversight of contamination control measures, including cleaning and disinfection practices.
o Leadership and collaboration to achieve sterility assurance objectives.
o Providing training on aseptic and contamination control principles.
o Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations.
o Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports.
Requirements
* Educational Background: Bachelor's degree in Microbiology, Biotechnology, or a related discipline.
* Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Aseptic Process Expertise: Proven experience in contamination control strategies, including cleaning and disinfection validation.
* Leadership Skills: Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives.
* Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions.
* Technical Proficiency: Proficient in the use of contamination control tools and monitoring systems.
* Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.