CSV Manager

1100 Mylan Pharmaceuticals Inc.; Galway; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression opportunities

Job summary

Viatris in Galway is seeking a CSV Manager to lead validation of GxP computerized systems. You will ensure compliance with regulatory standards, maintain validated systems, and guide end-to-end CSV projects.

The role requires a strong background in CSV activities, regulatory knowledge, and the ability to coordinate cross-functional teams to deliver compliant solutions. The company offers a competitive salary and benefits package.

Qualifications

• Bachelor's degree in computer science, information technology, engineering or related field.
• Experience delivering CSV activities and driving compliance.
• Knowledge of regulatory requirements and industry standards for GxP computerized systems.
• Ability to manage end-to-end CSV projects and related QA activities.

Responsibilities

• Prepare, execute and report GxP CSV deliverables at site.
• Ensure validation activities meet regulatory requirements and standards.
• Maintain validated state of GxP computerized systems at the site.
• Oversee projects, track progress and manage escalations.
• Provide inputs for CSV procedures and QMS document reviews.

Skills

CSV management

GxP compliance

Regulatory knowledge

Project coordination

Education

Bachelor's degree in CS/IT/Engineering

Job description

Mylan Teoranta Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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

The CSV Manager key will be responsible Every day, we rise to the challenge to make a difference and here’s how the CSV Manager role will make an impact:

• Preparation, execution and reporting of GxP computerized systems validation deliverables at site.
• Ensure all validation activities adhere to regulatory requirements and company standards.
• Ensure compliance of all GxP computerized systems validation activities at the site.
• Maintain the validated state of all GxP computerized systems used at the site.
• Oversee end-to-end implementation of assigned projects, including tracking progress, following up on tasks, and managing escalations.
• Ensure self-inspection and remediation activities related to GxP computerized systems.
• Conduct periodic reviews of all GxP computerized systems at the site to ensure continued compliance.
• Provide inputs for the revision and implementation of Computerized System Validation (CSV) procedures.
• Manage associated QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs.
• Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance.
• Ensure the site is prepared for all audits and actively participate during audit processes.
• Provide training to cross-functional team (CFT) members on CSV-related procedures.
• Maintain an updated inventory of GxP computerized systems.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Must possess strong knowledge of regulatory requirements and industry standards for GxP computerized systems Minimum of a Bachelor's degree (or equivalent) in computer science, Information Technology, Engineering or a related field with experience. However, a combination of experience and/or education will be taken into consideration Must possess demonstrated ability to drive compliance through delivery of CSV activities

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at 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. Some of our benefits include the following on top of a competitive salary:

• 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. 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

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.

Viatris is an Equal Opportunity Employer. Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.