Validation Manager

Job title:

Validation Manager

Company

Viatris

Job description

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; 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 DoingThe Validation Manager is responsible for ensuring the validation program, as developed and maintained, at Viatris is compliant with various regulatory guidelines and assures products and processes conform to established validation and qualification requirements and standards through appropriate team involvement and test activities. Every day, we rise to the challenge to make a difference and here’s how the Validation Manager role will make an impact:Maintain all required Validation Master plans for the site, ensuring they meet all applicable regulatory requirements.Facilitate and respond to all validation queries raised at site audits, both internal and external.Manage the annual Validation Re-Qualification and periodic Review Program.Manage all equipment, utility, process, computer systems and cleaning validation activities on site.Liaise with the production department and planning to ensure that validation conducted as part of the monthly schedules.Ensure all validation exercises are being executed in a manner compliant with regulatory guidelines.Provide documented support as required for regulatory submissions.Identify Validation requirements of introducing a new product to the Viatris portfolio.Oversee Software validations for quality systems e.g. MES / LIMSManage and schedule validations by external service providers as required.Write, review and approve SOPs, protocols, reports and other documentation as required.Manage and develop direct reports, including setting objectives, mentoring and performance management.Manage the departmental budget.Promote a culture of continuous improvement in the Validation DepartmentAbout 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 in a Technical, Science, Production or Process discipline and a minimum of 8+ years’ experience in a Validation with leadership experience.Project Management Certified (would be an advantage).Position directly supervises a no. of employees. Must carry out supervisory responsibilities in accordance with the organisation’s policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Benefits at ViatrisAt 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 opportunitiesWork-life balance initiativesBonus schemeHealth insurancePensionDiversity & Inclusion at ViatrisAt 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 visitSustainability at ViatrisCorporate 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 visitAt 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.

Expected salary

Location

Inverin, Co Galway

Job date

Thu, 16 May 2024 03:02:51 GMT

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