Posted: 18 June
The role
The Role & What You Will Be Doing
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.
Key Responsibilities
Driving Sterility Assurance Strategy
Oversight of Environmental Monitoring and Contamination Control
Support for Sterility-Related Validations and Audits
Leadership and Collaboration
Documentation and Reporting
Instrument and System Management
About Your Skills & Experience
Educational Background: A Bachelor’s degree in Microbiology, Biotechnology, or a related discipline, with 2–4 years of sterility assurance or aseptic manufacturing experience.
Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
Aseptic Process Expertise.
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, including MODA, Excel, and project management software.
Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.
Benefits at Viatris
Excellent career progression opportunities
Work‑life balance initiatives
Bonus scheme
Health insurance
Pension
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility.
Viatris is an Equal Opportunity Employer.
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