QbD Group

Automation & Data Integrity Specialist

QbD Group  â€˘  Breda, NL (Hybrid)  â€˘  4 months ago
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Job Description

🔍 Automation & Data Integrity Specialist

📍 Location Hybrid
đź•“ Type Full-time

Are you passionate about automation, analytical equipment, and data integrity in a regulated (GxP) environment? Do you enjoy working where quality, compliance, and technology meet — and making sure systems and processes are not only working, but audit-ready and future-proof?

We are looking for an Automation & Data Integrity Specialist who’s ready to support life sciences companies in building strong, compliant, and reliable processes across QC and production environments. In this role, you’ll apply ALCOA+ principles, strengthen data integrity governance, and support clients during implementations, validations, audits, and inspections

This position is ideal for someone who takes ownership, enjoys working across teams, and gets energy from solving complex quality and compliance challenges — while helping others grow along the way. If you’re ready to make an impact in the Life Sciences industry (and grow while doing it), we’d love to hear from you

💡 What’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse assignments that broaden your expertise in automation, data integrity, and compliance.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

🏢 What you’ll be doing

Tasks description

đź’Ş What you bring

  • Act as a Data Integrity (DI) specialist, monitoring and supporting compliance across QC and operational environments

  • Ensure data integrity compliance during implementation of analytical equipment and automated systems

  • Apply and embed ALCOA+ principles across processes, systems, and ways of working

  • Bring advanced expertise on data integrity expectations, standards, and best practices within regulated environments

  • Identify DI risks and issues, create and own Quality Risk Assessments, and ensure they lead to clear actions

  • Review outcomes of quality audits and inspections and support the development and execution of corrective and preventive action plans (CAPA)

  • Support or lead deviation management related to data integrity and compliance topics

  • Consult on new testing procedures and procedural changes, ensuring DI is built in from the start

  • Provide DI support during equipment validations (e.g., audit trail reviews/validation, system integrity checks)

  • Support DI guidance during change control, ensuring validated and compliant status is maintained

  • Deploy and own DI Gemba walks and translate observations into sustainable improvements

  • Lead or support data integrity governance processes and help strengthen standard ways of working

  • Support inspection readiness and collaborate in internal and external audits

  • Coach, train, and guide colleagues and stakeholders to raise awareness and maturity around DI

  • Work according to compliance best practices, EHSS requirements and lean principles

  • Perform other work-related activities assigned by your supervisor

🫵 Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

  • You’re resilient and tackle challenges with a positive mindset

  • You’re curious and always up for learning something new

  • You have a no non-sense approach honest, clear, respectful

  • You’re innovative and bring ideas, not just opinions

  • And above all, you’re serious about your work, but not too serious about yourself

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.

QbD Group

About QbD Group

The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 700 high-qualified employees.

Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions:

• Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.

• Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.

• Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software.

• Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities.

• Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

• Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU).

• Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.

Industry
Consulting & Advisory
Company Size
501-1,000 employees
Headquarters
Antwerp, BE
Year Founded
Unknown
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