Quality Validation Officer

6 days ago

Castle Donington, Leicestershire, United Kingdom Arvato Full time £42,000 per year

Salary: Up to £42,000.00
Location: Kings Norton / East Midlands Gateway
Hours: 40hours
Arvato UK is looking for a proactive
Quality Validation Officer
to support computerised system validation, compliance, and wider quality assurance activities within our Healthcare division. You will work closely with the Validation Manager to ensure systems (including SAP) and quality processes meet GDP, ISO, FDA, and EU Annex 11 standards.

Your Tasks

  • Lead and support Computer System Validation (CSV) activities, including planning, executing, and documenting validation, re-validation, and change controls for systems and associated applications.
  • Prepare and review test documentation, validation protocols, change requests, and evidence to ensure all system changes are fully justified, tested, approved, and compliant.
  • Conduct effectiveness checks, data integrity reviews, and periodic system archiving to maintain ongoing compliance.
  • Support the Quality Management System (QMS) by assisting with deviations, CAPAs, risk assessments, change controls, SOP creation, and document control activities.
  • Provide QA support and guidance to operational teams, ensuring project timelines and compliance requirements are met.
  • Deliver training sessions on validation, change control, and key quality processes to enhance compliance awareness across teams.
  • Participate in internal and external audits, support audit readiness, present validation documents to auditors, and contribute to CAPA closure.
  • Support quality metrics and KPI reporting, ensuring accurate data collection and timely completion of QMS actions.
  • Contribute to supplier validation, including questionnaires, performance reviews, and maintenance of validation schedules for critical equipment (e.g., temperature monitoring).
  • Assist in continuous improvement initiatives, promoting harmonisation of validation processes and identifying opportunities to strengthen system and process compliance.

Your Profile

  • Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems.
  • Strong documentation, analytical, and organisational skills.
  • Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11.
  • Experience in healthcare, pharmaceutical, or medical device environments.
  • Confident in audits, inspections, and presenting validation activities.

We Offer

  • 25 days annual leave plus 8 UK bank holidays with the option to purchase up to an additional 5 days
  • Pension contribution
  • A life assurance policy that pays out 4 x Salary
  • Employee Assistance Programme that provides you with confidential support, information, and advice to help you
  • Employee Discount Scheme through Treats
  • Free car parking

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