Norgine Limited logo

CSV Analyst - 12 Month Fixed Term Contract

Norgine LimitedHengoed, Wales, United Kingdom
On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Experience Level

Entry Level

Qualifications

Requirements:Assist the CSV/Lead Process Analyst in enhancing and executing the Global IT validation strategy while ensuring compliance with relevant GxP requirements (e.g., EU Annex 11, FDA 21 CFR Part 11, Part 820, etc.). Support the ongoing refinement of procedures for validating computerized systems. Develop, review, and approve CSV policies and procedures, championing their implementation. Collaborate with project teams to determine the necessary validation levels based on risk assessments. Assist in creating validation documentation to support the validated state. Engage with business functions for periodic system reviews to evaluate the current validated state. Serve as a quality contact and Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management. Review changes to validated computerized systems and define the validation requirements to maintain their validated status. Guide project teams in assessing new computerized systems or software for GxP implications, providing insights on risk-based validation approaches.

About the job

Embark on a fulfilling career journey with Norgine, where we encourage our team members to embrace unique perspectives and pursue innovative solutions. Here, we foster a vibrant culture of collaboration, continuous development, and community engagement.

Join us as a CSV Analyst for a 12-month fixed-term contract and be a pivotal part of our mission to deliver cutting-edge healthcare solutions that positively impact lives.

Core Responsibilities:

In this role, you will play a crucial part in ensuring that Norgine's IT Quality Management System, validation documentation, and all related processes adhere to applicable regulations. You will collaborate with team members and consultants to pinpoint areas for improvement and actively participate in implementing necessary changes.

If you're ready to develop a multi-faceted career in a leading healthcare organization, we invite you to apply.

About Norgine Limited

Norgine is a dynamic healthcare organization dedicated to transforming lives through innovative solutions. Our commitment to employee wellness and continuous upskilling creates a supportive environment where you can thrive.

Similar jobs

Browse all companies, explore by city & role, or SEO search pages. View directory listings: all jobs, search results, location & role pages.

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.