Validation Consultant - CSV & eCompliance

Pauwels Consulting; Gent; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Pauwels Consulting in Belgium is seeking a Validation Consultant to support its digital technology compliance team. The project focuses on managing the lifecycle of computer systems and supporting IT quality processes within R&D environments.

The role requires 5+ years of experience in regulated settings, deep knowledge of FDA 21 CFR Part 11, EU Annex 11 and ICH guidelines, and fluency in English. You will collaborate with cross‑functional teams to ensure data integrity, risk assessments, and

Qualifications

• Bachelor's or Master's degree in Computer Science, Life Sciences, or Engineering.
• 5+ years of experience as a validation consultant or quality manager for computer systems within GLP and GCP regulated environments.
• Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, and ICH Guidelines regarding data management.
• Expertise in Data Integrity controls and risk assessments using GAMP 5 or CSA frameworks.
• Experience managing early drug discovery, clinical, and pre-clinical biomarker data within cloud-based R&D platforms.
• Knowledge of AI governance frameworks, including Generative AI and LLMs.
• Autonomous professional with a critical mind, high attention to detail, and a pragmatic approach.
• Fluency in English.

Responsabilités

• Establish quality frameworks to maintain computerized systems in compliance with internal and external regulations such as data privacy and cybersecurity.
• Ensure project deliverables are complete, consistent, and delivered according to project timelines.
• Support the creation and review of validation and qualification SOPs and templates.
• Resolve computerized system validation and qualification compliance issues.
• Manage quality events including change controls, deviations, and CAPA.
• Communicate effectively with multidisciplinary stakeholders across research, development, and security departments.

Connaissances

Validation consulting

Quality management

Computer systems validation

Regulatory compliance (GLP/GCP)

Data integrity

GAMP 5 / CSA

FDA 21 CFR Part 11

EU Annex 11

ICH Guidelines

AI governance familiarity

Cloud-based R&D platforms

Stakeholder communication

Formation

Bachelor's or Master's in Computer Science, Life Sciences, or Engineering

Outils

Veeva

QMS

ServiceNow

Jira

Description du poste

Our client, a leading life sciences organization, is seeking a Validation Consultant to support their digital technology compliance team. The project focuses on managing the lifecycle of computer systems and supporting IT quality processes within research and development environments.

Responsibilities

• Establish quality frameworks to maintain computerized systems in compliance with internal and external regulations such as data privacy and cybersecurity.
• Ensure project deliverables are complete, consistent, and delivered according to project timelines.
• Support the creation and review of validation and qualification SOPs and templates.
• Resolve computerized system validation and qualification compliance issues.
• Manage quality events including change controls, deviations, and CAPA.
• Communicate effectively with multidisciplinary stakeholders across research, development, and security departments.

Requirements

• You have a Bachelor or Master in Computer Science, Life Sciences, or Engineering.
• You bring 5+ years of experience as a validation consultant or quality manager for computer systems within GLP and GCP regulated environments.
• You possess deep knowledge of FDA 21 CFR Part 11, EU Annex 11, and ICH Guidelines regarding data management.
• You have expertise in Data Integrity controls and risk assessments using GAMP 5 or CSA frameworks.
• You bring experience managing early drug discovery, clinical, and pre-clinical biomarker research data within cloud-based R&D platforms.
• You have knowledge of AI governance frameworks, including Generative AI and LLMs.
• You're an autonomous professional with a critical mind, high attention to detail, and a pragmatic approach.
• You are fluent in English.

Nice to Haves

• Experience with software systems such as Veeva, QMS, ServiceNow, or Jira.
• Proficiency with the latest MS Office software package.