CSV Specialist: Data Integrity & Validation Lead

MedPharm; England; On-site; GBP 60,000 - 90,000; Full time

Job summary

MedPharm is seeking a CSV Specialist to govern and validate GxP computerised systems at our site, ensuring compliance with EU GMP Annex 11, MHRA guidance, and GAMP5 principles. You will oversee the validation lifecycle, assess updates, and close CSV gaps to maintain inspection readiness and data integrity.

You will work with QA, IT and operations to define validation plans, support regulatory inspections, and develop templates aligned with best practices.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, or related discipline.
• 3–5 years’ CSV experience in GMP-regulated environments.
• Hands-on MasterControl (or equivalent eQMS) experience.
• Experience with EU GMP Annex 11 and GAMP5 guidance.

Responsibilities

• Own and maintain the CSV Master Plan.
• Manage full validation lifecycle of GxP systems (URS, IQ/OQ/PQ, validation reports).
• Assess updates and changes; approve via change control.
• Conduct risk-based impact assessments for changes.
• Prepare and maintain validation documentation and audit trails.
• Support regulatory inspections (MHRA, FDA) related to CSV.
• Collaborate with QA, IT, Operations and vendors.

Skills

CSV governance

Risk assessment

Documentation

Cross-functional collaboration

Regulatory inspections support

Education

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Computer Science, or related discipline

Tools

MasterControl

eQMS

Job description

MedPharm is seeking a CSV Specialist to govern and validate GxP computerised systems at our site, ensuring compliance with EU GMP Annex 11, MHRA guidance, and GAMP5 principles. You will oversee the validation lifecycle, assess updates, and close CSV gaps to maintain inspection readiness and data integrity.

You will work with QA, IT and operations to define validation plans, support regulatory inspections, and develop templates aligned with best practices.