Mylan TeorantaAt 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.We do so via:Access – Providing high quality trusted medicines regardless of geography or circumstance;Leadership – Advancing sustainable operations and innovative solutions to improve patient health; andPartnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience.
Viatris is more than just a place to work.
This is a place to make a difference in the world.The Role & What You Will Be DoingThe Senior Microbiologist will be responsible for overseeing microbiological activities in the laboratory, ensuring compliance with industry standards, and supporting investigations related to product quality and contamination issues.
This role involves managing investigations, working to update procedures and practices, and providing expert guidance during quality investigations.Every day, we rise to the challenge to make a difference and here's how the Grade 3 role will make an impact:Key Responsibilities:1.
Investigations Support:o Lead and support investigations into microbiological-related quality issues and contamination events.o Perform root cause analysis for deviations and non-conformances involving microbiological aspects.o Collaborate with cross-functional teams to develop corrective and preventive actions (CAPAs).o Document investigation findings and prepare detailed investigation reports.2.
QMS Support:o Actively participate in the microbiology QMS activities including updating procedures and practices to comply as per the approved CAPAs.o Create and update change controls related to microbiology and sterility assurance.o Ensure timely closure of quality records related to the microbiology department in accordance with site procedures and global quality standards.3.
Document Management:o Verify if the procedures/ documents/ logbooks are up to date.o Review and initiate changes in the procedures to comply as per the regulatory standards.o Review the documents and present if Errors.o Prepare Trends and present areas where there is scope for improvements.4.
Instrument / Equipment Management:o Ensure that the laboratory equipment's / instruments are maintained and calibrated.o Ensure that laboratory equipment are properly maintained.o Propose alternate or enhancement in the equipment management.o Should have expertise in MODA application.
Should be the SME on MODA.5.
Training:o Mentor microbiology staff, providing training and professional development opportunities.o Discuss with the team the routine errors and plan for improvements.6.
Quality Assurance and Compliance:o Ensure all microbiological testing complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).o Develop and update Standard Operating Procedures (SOPs) and work instructions.7.
Data Management and Reporting:o Maintain accurate and detailed records of all microbiological activities and results.o Prepare and present technical reports, summaries, and presentations for internal and external stakeholders.o Analyze data trends to identify potential areas of improvement and implement necessary changes.8.
Additional:o Support in developing new methods.o On need basis, support the laboratory in testing and execution of microbiological analysis and environmental monitoring.About Your Skills & ExperienceFor this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:· Minimum of a bachelor's degree (or equivalent) and 6 + 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 MODA.· Experience with sterile injectable products, aseptic manufacturing processes and contamination control strategies.· 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 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.At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.Viatris is an Equal Opportunity Employer.