CSV & Quality Systems Lead

Sciensus; Burton upon Trent; On-site; GBP 42,000 - 54,000; Full time

Benefits offered by this job

25 days annual leave

Life Assurance

Annual pay reviews

Pension scheme

Private medical insurance (BUPA)

Training opportunities

Job summary

Sciensus, Burton upon Trent, is seeking a CSV & Systems Officer to own validation activities and electronic quality systems, ensuring patient safety and regulatory compliance. You will lead validation planning, IQ/OQ/PQ, and support system upgrades and data integrity.

Working with Quality, Operations and IT, you will deliver training, dashboards, KPIs and contribute to continuous improvement, digitalisation and automation across the site.

Qualifications

• Experience with CSV validation activities and documentation.
• Experience administering quality management systems or regulated IT systems.
• Experience in GMP-regulated environments.
• Strong documentation writing skills and attention to detail.
• Experience managing change controls and risk assessments.

Responsibilities

• Develop, execute and maintain validation documentation (IQ/OQ/PQ, Validation Plans, URS, Risk Assessments).
• Administer eQMS and manage user access, permissions, reviews.
• Support system upgrades, testing activities and software releases.
• Ensure compliance with EU GMP Annex 11, GAMP 5 and Data Integrity (ALCOA+).
• Manage change controls, risk assessments, deviations and CAPAs.
• Support regulatory inspections, audits and supplier assessments.
• Provide user training and create guidance materials; offer first-line systems support.
• Produce compliance reports, KPIs and system performance metrics.
• Drive continuous improvement, digitalisation and automation across the site.

Skills

CSV experience

Quality systems administration

GMP environment

Documentation writing

Change controls & risk assessments

Education

Science/Pharmacy/Computer Science/QA degree

Tools

eQMS

Job description

Sciensus, Burton upon Trent, is seeking a CSV & Systems Officer to own validation activities and electronic quality systems, ensuring patient safety and regulatory compliance. You will lead validation planning, IQ/OQ/PQ, and support system upgrades and data integrity.

Working with Quality, Operations and IT, you will deliver training, dashboards, KPIs and contribute to continuous improvement, digitalisation and automation across the site.