CSV & Quality Systems Lead (GMP)

Sciensus; Burton upon Trent; On-site; GBP 36,000 - 48,000; Full time

Benefits offered by this job

25 days annual leave

Pension scheme

Private medical (BUPA)

Life Assurance

Annual company event

Refer a friend scheme

Training opportunities

Job summary

Sciensus is seeking a CSV & Systems Officer to own validation for GMP computerised systems and electronic quality management systems. You will work with Quality, Operations and IT to drive continuous improvement, support digitalisation projects and ensure data integrity across validation activities.

The role focuses on validation planning, IQ/OQ/PQ testing, change controls and regulatory compliance, with opportunities for professional development within a growing healthcare organisation.

Qualifications

• Degree in Science, Pharmacy, Computer Science, Quality Assurance or a related discipline.
• Experience of Computer System Validation (CSV).
• Experience administering quality management systems or other regulated IT systems.
• Experience working within a GMP-regulated environment.
• Experience writing and reviewing validation documentation.
• Experience managing change controls and risk assessments.

Responsibilities

• Developing, executing and maintaining validation documentation including Validation Plans, URS, Risk Assessments, IQ, OQ and PQ protocols.
• Administering electronic quality systems, including user access management, permissions and periodic account reviews.
• Supporting system upgrades, enhancements, testing activities and software releases.
• Ensuring compliance with EU GMP Annex 11, GAMP 5 principles and Data Integrity requirements.
• Managing system-related change controls, risk assessments, deviations and CAPAs.
• Supporting regulatory inspections, customer audits and supplier assessments.
• Delivering user training, creating guidance materials and providing first-line systems support.
• Producing compliance reports, KPIs and system performance metrics.
• Driving continuous improvement, digitalisation and automation initiatives across the site

Skills

CSV

GAMP 5

Data integrity

Documentation

Quality management systems

Stakeholder communication

Education

Science/Pharmacy/Computer Science/QA degree

Related discipline

Tools

eQMS software

Validation lifecycle tools

URs/IQ/OQ/PQ documents

Job description

Sciensus is seeking a CSV & Systems Officer to own validation for GMP computerised systems and electronic quality management systems. You will work with Quality, Operations and IT to drive continuous improvement, support digitalisation projects and ensure data integrity across validation activities.

The role focuses on validation planning, IQ/OQ/PQ testing, change controls and regulatory compliance, with opportunities for professional development within a growing healthcare organisation.