Senior Microbiology Team LeadLocation: Inverin, County Galway, Ireland
Time Type: Full time
Posted on: Posted 10 Days Ago
Job Requisition ID: R5646358
About Viatris At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life.
The Role & What You Will Be Doing The Senior Microbiology Team Leader will lead a team of Microbiology Technicians in ensuring the quality and safety of sterile injectable products. The role is responsible for overseeing microbiological testing, method validation, environmental monitoring, and contamination control in compliance with regulatory guidelines.
Every day, we rise to the challenge to make a difference and here's how the Senior Microbiology Team Leader role will make an impact:
Co-ordinate and supervise all microbiological testing within the Microbiology Lab, ensuring all activities are carried out in a timely manner to meet company objectives.Review and approve batch release documentation, raw material and stability data.Provide guidance, coaching, and expertise to the Microbiology team, establishing employee goals and objectives and maximizing development opportunities.Co-ordinate and supervise Microbiology Laboratory Investigations.Ensure the highest quality standards are maintained in areas of responsibility and that industry best practices are adopted in accordance with current GMP, GLP, and regulatory directives.Responsible for the co-ordination of the Microbiology Department SOP updates, change controls, deviations, investigations, and trend reports.Scheduling of instrument calibrations and maintenance.Ensure validity of all test methods in the laboratory are established and documented.Act as Designee/Deputy for Microbiology Lab Manager.Manage and review the environmental monitoring program to ensure aseptic conditions in the manufacturing areas.Investigate environmental monitoring out of specification results, determine root cause, and implement corrective actions.Oversee the scheduling of the Aseptic process simulations and support the review and approval of the reports.Participate in the implementation and maintenance of a comprehensive contamination control strategy for the sterile manufacturing processes.Track and report quality system metrics relevant to testing and investigations.Participate in internal and external audits, support the provision of responses for any microbiology citations, and represent the microbiology department in audit discussions relating to environmental monitoring and contamination control.About Your Skills & Experience Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience. However, a combination of experience and/or education will be taken into consideration.Knowledge of Annex I and US and EMA GMP regulations.Have working knowledge of isolator technology.Have working knowledge of MODA.Experience with sterile injectable products, aseptic manufacturing processes, and contamination control strategies.Excellent leadership, communication, and problem-solving skills required.Ability to work cross-functionally with other departments (Analytical, Quality, Manufacturing, and Regulatory).Proficient computer skills (Excel, Word, PowerPoint, databases, Microsoft project planning or similar software).Must possess excellent planning and organizational skills, be able to work in a fast-paced environment, adjust quickly to changing priorities, and handle multiple tasks simultaneously.Ability to read and interpret complex business and/or technical documents and to write comprehensive reports and detailed business correspondence.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 not as it is, but as it should be.
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.
Viatris is an Equal Opportunity Employer.
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