Bertelsmann is a media, services and education company that operates in about 50 countries around the world. It includes the broadcaster RTL Group, the trade book publisher Penguin Random House, the magazine publisher Gruner + Jahr, the music company BMG, the service provider Arvato, the Bertelsmann Printing Group, the Bertelsmann Education Group, and Bertelsmann Investments, an international network of funds. The company has 117,000 employees and generated revenues of €17.1 billion in the 2015 financial year. Bertelsmann stands for creativity and entrepreneurship. This combination promotes first-class media content and innovative service solutions that inspire customers around the world
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
Profile