CSV Specialist: GxP Systems Lifecycle & Data Integrity

MedPharm; England; On-site; GBP 60,000 - 85,000; Full time

Job summary

MedPharm seeks a Computer System Validation (CSV) Specialist to govern and manage the lifecycle of GxP computerised systems at the site. You will ensure compliance with EU GMP Annex 11, MHRA guidance, and GAMP5, while providing technical oversight of electronic systems and data integrity.

You will lead validation activities, assess system changes, and close CSV gaps to support inspection readiness. Collaboration with QA, IT, Operations, and vendors is essential.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, or related discipline.
• Minimum 3–5 years’ experience in Computer System Validation within GMP environments.
• Hands-on experience with MasterControl/eQMS for validation lifecycle management.
• Experience validating GxP systems per EU GMP Annex 11 and GAMP5.
• Experience supporting regulatory inspections related to CSV and data integrity.

Responsibilities

• Own and maintain the CSV Master Plan for the site.
• Manage full validation lifecycle of GxP systems (URS, IQ/OQ/PQ, reports).
• Assess and approve system updates and changes under change control.
• Conduct risk-based impact assessments for changes and new implementations.
• Perform periodic reviews to maintain validated state.
• Close CSV gaps to ensure Annex 11 and data integrity compliance.

Skills

CSV Master Plan

Validation Lifecycle

Risk Assessment

Change Control

GAMP5

Data Integrity

Regulatory Inspections

Documentation Review

Education

Bachelor’s degree (Life Sciences/Pharmacy/Engineering/CS)

Tools

MasterControl

eQMS

Microsoft Office

Job description

MedPharm seeks a Computer System Validation (CSV) Specialist to govern and manage the lifecycle of GxP computerised systems at the site. You will ensure compliance with EU GMP Annex 11, MHRA guidance, and GAMP5, while providing technical oversight of electronic systems and data integrity.

You will lead validation activities, assess system changes, and close CSV gaps to support inspection readiness. Collaboration with QA, IT, Operations, and vendors is essential.