We're on it. Are you on it?
At Arvato, quality is never an afterthought, it's at the core of everything we do. We work for leading healthcare clients in a highly regulated environment, supported by smart IT systems and continuously evolving processes. To keep our systems compliant, validated and audit?'ready, we're looking for a Quality Specialist CSV.
In this role, you'll be part of the Quality team, with a clear specialization in Computerized System Validation (CSV). You'll make sure our computerized systems meet regulatory requirements and remain reliable, secure and compliant throughout their entire lifecycle.
YOUR TASKS
As Quality Specialist CSV, you are the link between Quality, IT and Operations. You like structure, documentation and system logic. You're not afraid to take ownership.
What you'll do:
- Central point of contact You coordinate (re)validation activities for computerized systems and manage change control processes end?'to?'end.
- Ownership of the CSV lifecycle From validation and periodic reviews to revalidation and system retirement. You keep the overview and ensure compliance at every step.
- Audit & inspection support You monitor actions, perform effectiveness checks and confidently represent CSV topics during audits and inspections.
- Deviation management & documentation You report, document and follow up on quality?'related deviations and support corrective and preventive actions.
- Independent change processing You prepare and process change requests, gather required input, plan and execute tests, create test matrices and review documentation.
- Coordination across healthcare clients You align CSV activities for multiple healthcare customers, including implementations, revalidations, archiving obligations and system retirements.
YOUR PROFILE
- You don't need to be a senior CSV expert yet. Motivation and a solid foundation matter most.
- You have a completed Bachelor's degree (commercial, technical or life?'science related);
- You have initial experience in Quality Assurance and Computerized System Validation (CSV);
- You enjoy working with systems and have experience with ERP software (e.g. SAP) and MS Office;
- You have knowledge of relevant regulations such as GDP, ISO 13485 and MDR (or are eager to deepen this knowledge);
- You work accurately, independently and enjoy collaborating with different stakeholders;
- You communicate professionally in English (Dutch is a plus).
WE OFFER
- Between €2.580 - €4.722, and we top it off with 8% holiday allowance and discounted gym memberships;
- Bonus scheme;
- 25 paid vacation days, possibility to extend these to 28 vacation days;
- Versatile working environment with creative freedom, flat hierarchies and an open corporate culture;
- Opportunity to accompany the development of one of the most modern logistics centers in Europe from the very beginning and to quickly take on responsibility;
- Very good development opportunities at a growing logistics location.