CSV Analyst - 12-Month Contract (GxP & Validation)

Internetwork Expert; Hengoed; On-site; GBP 40,000 - 60,000; Full time

Job summary

Norgine in the United Kingdom is seeking a CSV Analyst on a 12-month fixed-term contract (FTC) to join our IT Quality Management team. You will work on validation documentation, regulatory compliance, and risk-based validation for computerized systems as part of a multi-disciplinary group.

You will develop and implement CSV policies, support project teams, assist in audits, and maintain the Local Validation Master Plan, collaborating with cross-functional groups in a fast-paced healthcare

Qualifications

• Bachelor's degree preferred in a relevant field.
• Experience validating and qualifying complex computer systems.
• Thorough knowledge of cGMP regulations related to CSV.
• Strong written and oral communication skills.
• Proficient in Microsoft Office.

Responsibilities

• Assist the CSV/Lead Process Analyst in improving the validation strategy and approach considering GxP requirements.
• Develop, review and approve CSV policies, procedures, plans and protocols.
• Support project teams in risk-based validation.
• Review changes to validated systems and identify validation requirements after changes.
• Maintain Local Validation Master Plan aligned to corporate policies.
• Assist in audits and respond to audit observations.
• Interact with management and other areas to implement and maintain Quality Systems.

Skills

ERP & BI

CSV system experience

Regulatory requirements

Data integrity

Education

Bachelor’s degree preferred

Validation of complex computer systems

cGMP CSV knowledge

Tools

Microsoft Office

Job description

Norgine in the United Kingdom is seeking a CSV Analyst on a 12-month fixed-term contract (FTC) to join our IT Quality Management team. You will work on validation documentation, regulatory compliance, and risk-based validation for computerized systems as part of a multi-disciplinary group.

You will develop and implement CSV policies, support project teams, assist in audits, and maintain the Local Validation Master Plan, collaborating with cross-functional groups in a fast-paced healthcare