Sterility assurance lead

The Role & What You Will Be DoingThe 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 ResponsibilitiesDriving Sterility Assurance StrategyOversight of Environmental Monitoring and Contamination ControlSupport for Sterility-Related Validations and AuditsLeadership and CollaborationDocumentation and ReportingInstrument and System ManagementAbout Your Skills & ExperienceEducational 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 ViatrisExcellent career progression opportunitiesWork life balance initiativesBonus schemeHealth insurancePensionViatris is an Equal Opportunity Employer.
#J-18808-Ljbffr