CSV & IT Validation Analyst – 12-Month FTC

Norgine Pharma SA; Hengoed; On-site; GBP 45,000 - 65,000; Full time

Job summary

Norgine in the United Kingdom is offering an exciting 12-month fixed-term contract for a CSV Analyst to join the IT Quality Management team. You will help ensure that validation activities, documentation and systems meet EU Annex 11 and 21 CFR Part 11 requirements, working with cross-functional colleagues and external consultants.

You will develop, review and implement CSV policies and plans, support risk-based validation, tests, audits, and maintain the Local Validation Master Plan, aiming to

Qualifications

• Bachelor’s degree preferred.
• Experience in validation and qualification of complex computer systems.
• Thorough knowledge of cGMP regulations related to CSV.
• Good written and oral communication skills.
• Competent user of Microsoft Office.

Responsibilities

• Assist the CSV/Lead Process Analyst in improving and delivering the global IT validation strategy.
• Support the validation of computerized systems and the risk-based validation approach.
• Develop, review and approve CSV policies, procedures, plans and protocols.
• Support project teams in defining validation levels based on risk assessments.
• Support the creation of validation packs to support the validated state.
• Maintain the Local Validation Master Plan and respond to audits and observations.
• Act as a Quality SME for CSV and Risk Management and coordinate with stakeholders.
• Provide guidance on GxP impact for new systems and ensure testing plans and scripts meet regulatory requirements.

Education

Bachelor’s degree

Experience in validation and qualification of complex computer systems

Thorough knowledge of cGMP regulations related to CSV

Good written and oral communication skills

Competent user of Microsoft Office

Job description

Norgine in the United Kingdom is offering an exciting 12-month fixed-term contract for a CSV Analyst to join the IT Quality Management team. You will help ensure that validation activities, documentation and systems meet EU Annex 11 and 21 CFR Part 11 requirements, working with cross-functional colleagues and external consultants.

You will develop, review and implement CSV policies and plans, support risk-based validation, tests, audits, and maintain the Local Validation Master Plan, aiming to