Quality Validation Officer

Arvato SCM UK Ltd; Lockington; On-site; GBP 35,000 - 42,000; Full time

Job summary

A major logistics and services company in Lockington is looking for a proactive Quality Validation Officer to manage computerised system validation and quality assurance activities. The candidate must have experience with enterprise systems like SAP and possess strong analytical, documentation, and organisational skills. Responsibilities include leading validation activities, supporting compliance with GDP and ISO standards, conducting audits, and providing QA guidance. This role offers competitive benefits including 25 days of leave plus bank holidays, a pension contribution, and life assurance.

Benefits

25 days annual leave plus bank holidays

Pension contribution

Life assurance policy

Employee Assistance Programme

Employee Discount Scheme

Free car parking

Qualifications

• Experience with SAP or other enterprise systems is essential.
• Strong documentation, analytical, and organisational skills are required.
• Knowledge of GAMP 5, validation principles, and regulatory standards is necessary.

Responsibilities

• Lead and support Computer System Validation (CSV) activities.
• Prepare and review test documentation and validation protocols.
• Conduct effectiveness checks and maintain compliance with quality standards.

Skills

Strong documentation skills

Analytical skills

Organisational skills

Tools

SAP

Electronic QMS

Temperature monitoring systems

Job description

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: 40 hours

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
• Life assurance policy that pays out 4 × Salary
• Employee Assistance Programme that provides you with confidential support, information, and advice to help you
• Employee Discount Scheme through Treats
• Free car parking