Automation and Data Integrity Specialist

QbD Group

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profile Job Location:

Breda - Netherlands

profile Monthly Salary: Not Disclosed
Posted on: 4 hours ago
Vacancies: 1 Vacancy

Job Summary

Automation & Data Integrity Specialist

Location: Hybrid
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 whos ready to support life sciences companies in building strong compliant and reliable processes across QC and production this role youll 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 youre ready to make an impact in the Life Sciences industry (and grow while doing it) wed love to hear from you

Whats 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 youll be doing

Tasks description

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 youll fit right in:

  • Youre resilient and tackle challenges with a positive mindset

  • Youre curious and always up for learning something new

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

  • Youre innovative and bring ideas not just opinions

  • And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.

Automation & Data Integrity Specialist Location: Hybrid Type: Full-timeAre 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 w...
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