GxP CSV Specialist – Validation & Compliance Lead

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

Job summary

MedPharm Ltd in Guildford is seeking a CSV Specialist to govern and manage validated computerised systems (GxP) across the site, ensuring compliance with EU GMP Annex 11 and MHRA guidance.

You will oversee the validation lifecycle (URS, IQ/OQ/PQ, reports), assess updates, perform risk assessments, and support inspections, collaborating with QA, IT, and operations to maintain data integrity. This on-site role requires 3–5 years CSV experience and a Life Sciences or related degree.

Qualifications

• Bachelor's degree and 3–5 years' CSV experience in GMP environment.
• Demonstrated hands-on experience with MasterControl (or equivalent eQMS).
• Experience validating GxP systems per EU GMP Annex 11 and GAMP5.
• Experience supporting regulatory inspections (MHRA, FDA).

Responsibilities

• Own and maintain the CSV Master Plan.
• Oversee full validation lifecycle of GxP systems (URS, IQ/OQ/PQ, reports).
• Assess and approve system updates and changes per change control.
• Conduct risk-based impact assessments for system changes.
• Perform periodic reviews to ensure validated state and data integrity.
• Support inspections and collaborate with QA, IT, Operations, vendors.
• Develop and maintain CSV templates and best practices.

Skills

CSV governance

Regulatory compliance

Validation lifecycle

GxP expertise

Risk assessment

Audits support

Change control

Documentation

Communication

Microsoft Office

MasterControl

Regulatory inspections

Education

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

Tools

MasterControl eQMS

Job description

MedPharm Ltd in Guildford is seeking a CSV Specialist to govern and manage validated computerised systems (GxP) across the site, ensuring compliance with EU GMP Annex 11 and MHRA guidance.

You will oversee the validation lifecycle (URS, IQ/OQ/PQ, reports), assess updates, perform risk assessments, and support inspections, collaborating with QA, IT, and operations to maintain data integrity. This on-site role requires 3–5 years CSV experience and a Life Sciences or related degree.