CSV & Systems Lead — Quality & Digitalisation

Sciensus Pharma Services Limited; Burton upon Trent; On-site; GBP 35,000 - 55,000; Full time

Benefits offered by this job

25 days annual leave + bank holidays

Yearly pay reviews

Life Assurance

Annual company event

Refer a friend scheme

Pension scheme

Private medical (BUPA)

Salary sacrifice schemes

Discount & cashback portal

Training opportunities

Well-being initiatives

Volunteer day

Job summary

Sciensus Pharma Services Limited in Burton upon Trent seeks a CSV & Systems Officer to own validation of computerised systems and electronic quality management systems, ensuring patient safety, product quality and regulatory compliance.

You will lead validation activities, administer access, support upgrades, and deliver reports while supporting continuous improvement in a GMP environment with cross-functional teams.

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.
• Knowledge of EU GMP Annex 11, GAMP 5, Data Integrity/ALCOA+ and Quality Management Systems.
• Validation lifecycle management.

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 experience

QMS administration

Validation docs

Regulated IT

Stakeholder management

Attention to detail

Education

Degree in Science/Pharmacy/CS/QA

Tools

eQMS software

Job description

Sciensus Pharma Services Limited in Burton upon Trent seeks a CSV & Systems Officer to own validation of computerised systems and electronic quality management systems, ensuring patient safety, product quality and regulatory compliance.

You will lead validation activities, administer access, support upgrades, and deliver reports while supporting continuous improvement in a GMP environment with cross-functional teams.