CSV Specialist: GxP Validation & Data Integrity

QbD Group; Noord-Brabant; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Tailored, transparent compensation

Knowledge-sharing and mentoring

Opportunity to shape future projects

Job summary

A leading consulting firm in life sciences is seeking a Computer System Validation Specialist to ensure compliance and data integrity for GxP systems. You'll apply GAMP5 guidelines, collaborate with cross-functional teams, and manage validation activities. Ideal candidates have a degree in a scientific discipline, solid experience in the life sciences, and a passion for quality and compliance, along with strong problem-solving skills.

Qualifications

• Hands-on experience in the Life Sciences industry or software-driven projects.
• Understanding of GAMP5, USFDA 21 CFR Part 11, and Eudralex Annex 11.
• Ability to write and review user requirements and validation plans.

Responsibilities

• Ensure that GxP-relevant systems are compliant and audit-ready.
• Collaborate across teams to elevate partnerships.
• Execute required tests and manage periodic reviews and revalidation.

Skills

Attention to detail

Collaboration

Problem-solving

Technical understanding of IT systems

Project management skills

Education

Bachelor’s or Master’s degree in a scientific or engineering discipline

Tools

Manufacturing Execution Systems (MES)

GAMP5 guidelines

Job description

A leading consulting firm in life sciences is seeking a Computer System Validation Specialist to ensure compliance and data integrity for GxP systems. You'll apply GAMP5 guidelines, collaborate with cross-functional teams, and manage validation activities. Ideal candidates have a degree in a scientific discipline, solid experience in the life sciences, and a passion for quality and compliance, along with strong problem-solving skills.