Manager QA IT Based Anywhere in Europe
Manager QA IT Based Anywhere in Europe
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Job Description
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.
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; and
Partnership 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 Doing
Every day we rise to the challenge to make a difference and heres how the Manager QA IT role will make an impact:
Computer System Validation (CSV) & IT Oversight - lead and support validation activities for laboratory and manufacturing systems (LIMS CDS MES EBR QMS etc.). Ensure systems comply with 21 CFR Part 11 Annex 11 and other applicable data integrity requirements. Review and approve user requirements validation documentation and change controls related to computerized systems.
Quality & Compliance - ensure data integrity across all computerized systems in compliance with ALCOA principles. Develop and review protocols and policies related to electronic systems and IT quality processes.
Collaboration & Support - act as liaison between QA IT laboratory staff and manufacturing operations. Train users on data integrity electronic records and compliance with IT-related systems. Support electronic quality management systems (QMS) for deviations and change management.
Risk & Security - conduct IT-related risk assessments for laboratory and manufacturing systems. Oversee access controls audit trails and cybersecurity considerations for regulated systems. Support disaster recovery planning and data backup/restore processes in alignment with compliance requirements.
Change control SOP/Guideline management Risk Analysis CSV lifecycle based on ISPE GAMP5 guidance and Periodic Reviews
Perform other duties as assigned.
About Your Skills & Experience
For this role were looking for a candidate who has an effective combination of the following qualifications skills and experiences:
Bachelors degree in Life Sciences Computer Science Information Technology or related field. Extensive years of experience in IT within a pharmaceutical biotech or medical device industry.
Knowledge of FDA EMA and ICH regulations including 21 CFR Part 11 and EU Annex with Computer System Validation (CSV).
Understanding of laboratory and manufacturing computerized systems (LIMS CDS MES EBR TrackWise Master Control etc.).
Ability to interpret regulatory requirements and apply them to IT and digital systems.
Problem-solving risk assessment and documentation skills.
Familiarity with GAMP 5 guidelines for computerized systems.
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.
Ability to perform computations such as percentages ratios and rates.
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt fully align with every requirement we still encourage you to apply. You may just be the right candidate for this or other roles.
Why Viatris
At Viatris we offer competitive salaries benefits and an inclusive environment where you can use your experiences perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
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. If you would like to know more about what diversity equity and inclusion means to us please visit 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 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.
Required Experience:
Manager
Employment Type
Full-Time
