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- Tasks: Lead quality validation activities and ensure compliance with industry standards in healthcare.
- Company: Join Bertelsmann, a global leader in media and services with a creative culture.
- Benefits: Enjoy competitive salary, generous leave, pension contributions, and employee discounts.
- Why this job: Make a real impact in healthcare by ensuring quality and compliance in innovative systems.
- Qualifications: Experience with SAP and knowledge of validation principles required.
- Other info: Dynamic role with opportunities for professional growth and development.
The predicted salary is between 30000 - 42000 £ per year.
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.
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.
Quality Validation Officer in Lockington employer: Arvato SCM UK Ltd
Contact Detail:
Arvato SCM UK Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Validation Officer in Lockington
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Bertelsmann or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by practising common questions related to quality validation and compliance. We recommend using the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your experience effectively.
✨Tip Number 3
Showcase your skills with real examples! When discussing your experience, highlight specific projects where you led validation activities or improved processes. This will demonstrate your hands-on expertise and problem-solving abilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Quality Validation Officer in Lockington
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Validation Officer role. Highlight your experience with SAP, validation principles, and any relevant healthcare or pharmaceutical background. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Keep it concise but engaging – we love a good story!
Show Off Your Documentation Skills: Since this role involves a lot of documentation, make sure to showcase your strong organisational and analytical skills. Mention specific examples where you've successfully managed documentation in previous roles – it’ll help us see your attention to detail!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Arvato SCM UK Ltd
✨Know Your Standards
Familiarise yourself with GDP, ISO, FDA, and EU Annex 11 standards. Being able to discuss these in detail will show that you understand the compliance landscape and can contribute effectively to the Quality Validation Officer role.
✨Showcase Your Experience
Prepare specific examples from your past work that demonstrate your experience with SAP or other enterprise systems. Highlight any relevant projects where you led validation activities or supported quality assurance processes.
✨Be Audit-Ready
Brush up on your audit skills! Be ready to discuss how you've prepared for audits in the past, what documentation you provided, and how you ensured compliance. This will reassure them of your capability to handle internal and external audits.
✨Engage with Continuous Improvement
Think about ways you've contributed to continuous improvement initiatives in previous roles. Be prepared to share ideas on how you can help harmonise validation processes and strengthen compliance at Bertelsmann.
