IT Validation Associate Manager
Location: Inverin, County Galway, Ireland
Time Type: Full-Time
Posted On: Offer published yesterday
Job Requisition ID: R5648842
About Viatris
At Viatris, we envision health not just as it is but as it should be. We act with courage, and our unique positioning provides stability in a world where health needs are constantly evolving. Viatris empowers everyone worldwide to live healthier at every stage of life.
The Role & What You Will Be Doing
The purpose of this role is to execute and review activities in compliance with Mylan's CSV program. The designated person will take a self-driven approach in the capacity of computer system validations and associated areas.
Every day, we rise to the challenge to make a difference, and here’s how the IT Validation Associate Manager role will make an impact:
* Preparation, execution, and reporting of GxP computerized systems validation deliverables at the 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.
* Perform other duties as assigned.
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 4-6 years of 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. 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:
* Excellent career progression opportunities.
* Work-life balance initiatives.
* Bonus scheme.
* Health insurance.
* Pension.
Diversity & Inclusion 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.
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