Quality Assurance & Qualification and Validation Specialist

Quality Assurance & Qualification and Validation Specialist

Location: Hybrid - Madrid

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 professional 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.

• 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.

• 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 are confident navigating regulatory landscapes, with working knowledge of GMP, FDA, EMA, and local quality guidelines.
• You are proactive, results‑oriented, and flexible — someone who pays attention to the details, takes ownership, and thrives both independently and in close collaboration with others.

• You are resilient and tackle challenges with a positive mindset.
• You are curious and always up for learning something new.
• You have a no‑non‑sense approach: honest, clear, respectful.
• You are innovative and bring ideas, not just opinions.
• You are serious about your work, but not too serious about yourself.