QbD Group

Quality Assurance & Qualification and Validation Specialist

QbD Group  â€˘  Pozuelo de AlarcĂłn, ES (Hybrid)  â€˘  4 hours ago
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Job Description

🔍Quality Assurance & Qualification and Validation Specialist

📍 Location Hybrid - Madrid
đź•“ Type Full-time

Are you the kind of person who won’t rest until every system, process, and piece of equipment runs exactly as it should and can prove it?

We’re looking for a Quality Assurance & Qualification and Validation Specialist who’s passionate about quality, precision, and ensuring that life-saving products are backed by rock-solid compliance.

In this hybrid role, you'll play a vital part in ensuring that critical equipment, systems, and quality processes meet the highest regulatory standards; from installation and performance qualification to batch release and continuous improvement. If you thrive on structure, take ownership of quality outcomes, and enjoy solving both technical and compliance challenges, this could be the perfect next step in your career in the pharmaceutical or life sciences industry.

💡 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, challenging assignments that broaden your expertise.

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

Main responsibilities:

  • Execute and document process validations (IQ/OQ/PQ) and test method validations in line with regulatory standards.

  • Proactively identify critical process parameters and conduct risk assessments.

  • Build hands-on GMP experience: review batch records, support materials release and manage the batch release process.

  • Lead nonconformance investigations and CAPAs, ensuring clear action plans and timely resolution.

  • Ensure data integrity and traceability across all quality records.

  • Get exposure to audits & inspections: Support inspections and learn how to prepare documentation and interact with authorities.

  • Prepare data-driven reports and present recommendations to management and stakeholders.

  • Deliver hands-on training in validation and quality systems.

  • Drive continuous improvement of quality policies and validation procedures.

đź’Ş What you bring

  • You bring a solid academic foundation with a BSc degree in Life Sciences, Exact Sciences, Computer Science, or Engineering

  • You have hands-on experience in QA, computer system validation (CSV), or automated processes, and a practical understanding of validating products, equipment, processes, risk management, and data integrity

  • You’re confident navigating regulatory landscapes, with working knowledge of GMP, FDA, EMA, and local quality guidelines.

  • You’re proactive, results-oriented, and flexible — someone who pays attention to the details, takes ownership, and thrives both independently and in close collaboration with others

🫵 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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