GxP CSV Specialist: Validation & Compliance

MedPharm Ltd; Guildford; On-site; GBP 52,000 - 70,000; Full time

Job summary

MedPharm Ltd in the United Kingdom seeks a Computer System Validation (CSV) Specialist to govern validation of GxP‑relevant computerised systems on site, ensuring compliance with EU GMP Annex 11, MHRA Data Integrity Guidance, and GAMP5 principles. The role provides technical oversight of electronic systems, manages validation activities, and closes CSV compliance gaps to maintain inspection readiness.

Responsibilities include owning the CSV Master Plan, managing URS/IQ/OQ/PQ, risk assessments,

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, or related discipline (or equivalent).
• Minimum 3–5 years’ CSV experience in GMP-regulated env.
• Hands‑on experience with MasterControl (or equivalent eQMS).
• Practical experience validating GxP systems per EU GMP Annex 11 and GAMP5.
• Experience supporting regulatory inspections (MHRA, FDA) related to CSV and data integrity.

Responsibilities

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

Skills

GxP compliance

Validation lifecycle management

GAMP5 methodology

Regulatory inspections support

Cross-functional collaboration

Documentation & reporting

Education

Bachelor’s degree in Life Sciences/Engineering/CS

Tools

MasterControl

eQMS

Job description

MedPharm Ltd in the United Kingdom seeks a Computer System Validation (CSV) Specialist to govern validation of GxP‑relevant computerised systems on site, ensuring compliance with EU GMP Annex 11, MHRA Data Integrity Guidance, and GAMP5 principles. The role provides technical oversight of electronic systems, manages validation activities, and closes CSV compliance gaps to maintain inspection readiness.

Responsibilities include owning the CSV Master Plan, managing URS/IQ/OQ/PQ, risk assessments,