Senior IT Validation & Quality Consultant (CSV)

Pauwels Consulting; Zwijnaarde; Sur place; EUR 110 000 - 140 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking a senior Validation Consultant / Quality Manager to ensure lifecycle management and compliance for computerized systems in a regulated biotech/pharma environment. You will author, review, and approve validation deliverables and drive quality across projects.

Requirements include 8+ years in validation or quality roles, deep regulatory knowledge (FDA Part 11, EU Annex 11, GAMP5), and hands-on experience with Azure/AWS/OCI, Snowflake or Databricks, and BI tools.

Qualifications

• 8+ years as Validation Consultant or Quality Manager in pharma/biotech.
• Deep knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP5, CSA.
• Experience validating infrastructure and cloud platforms.
• Hands-on with Snowflake or Databricks and BI tools.
• Fluent in English with strong communication.

Responsabilités

• Write, review, and approve validation deliverables in electronic document management.
• Ensure compliance with GxP, SOx, and data privacy regulations.
• Deliver validation projects within timelines and quality standards.
• Develop and review validation SOPs and templates.
• Handle CAPAs, deviations, and change controls; manage quality events.
• Coordinate with quality, data engineering, and security stakeholders.

Connaissances

Validation expertise

Regulatory knowledge

Cloud platforms

Data warehousing

BI tools

AI governance

Communication

English fluency

Formation

Master or Bachelor in Computer Science / Life Sciences / Engineering

Outils

Veeva

ERP

QMS

ServiceNow

Jira

Description du poste

Pauwels Consulting is seeking a senior Validation Consultant / Quality Manager to ensure lifecycle management and compliance for computerized systems in a regulated biotech/pharma environment. You will author, review, and approve validation deliverables and drive quality across projects.

Requirements include 8+ years in validation or quality roles, deep regulatory knowledge (FDA Part 11, EU Annex 11, GAMP5), and hands-on experience with Azure/AWS/OCI, Snowflake or Databricks, and BI tools.