Life Sciences Equipment Qualification Specialist

QbD Group

Barcelona

On-site

EUR 52,000 - 76,000

Full time

28 hours ago
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Job summary

QbD Group in Barcelona is seeking a Qualification & Validation Specialist who thrives on quality, precision, and compliance to ensure life sciences systems and equipment meet the highest standards from installation through performance.

You will lead validation activities (IQ/OQ/PQ), support CSV, drive CAPA investigations, and help maintain audit-ready documentation, data integrity, and change control across projects in pharma, biotech, and medical devices.

Qualifications

  • QA, computer system validation (CSV), and automated processes experience.
  • Validation of products, equipment, processes, risk management, and data integrity.
  • Proficiency navigating GMP, FDA, EMA and local quality guidelines; Annex 1 awareness.
  • Proactive, results-oriented, and detail-focused; capable of independent and collaborative work.

Responsibilities

  • Bring a quality-first mindset to validation and qualification activities, ensuring alignment with internal policies and regulatory standards.
  • Collaborate on IQ/OQ/PQ validations and test method validations, turning technical precision into shared success.
  • Drive nonconformance and CAPA investigations with clear action plans and timely resolution.
  • Proactively share insights to enhance quality policies and validation procedures, helping the team grow stronger.
  • Represent QA as a trusted partner in cross-functional projects with expertise and enthusiasm.
  • Provide hands-on training, coaching, and support in validation, quality systems, and CSV.
  • Ensure change control processes are followed and audits remain ready throughout lifecycle.
  • Monitor performance with regular system reviews to ensure ongoing compliance and improvements.
  • Implement data integrity and traceability controls to tell the full quality story.
  • Step up as SME during internal and external audits with confidence and clarity.

Skills

QA experience
CSV expertise
GMP knowledge
Regulatory knowledge
CAPA investigations

Education

BSc in Life Sciences
BSc in Exact Sciences
BSc in Computer Science
BSc in Engineering

Job description

QbD Group in Barcelona is seeking a Qualification & Validation Specialist who thrives on quality, precision, and compliance to ensure life sciences systems and equipment meet the highest standards from installation through performance.

You will lead validation activities (IQ/OQ/PQ), support CSV, drive CAPA investigations, and help maintain audit-ready documentation, data integrity, and change control across projects in pharma, biotech, and medical devices.

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