Validation Consultant - CSV & IT Quality

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

Our client, a global biotechnology organization, is seeking a professional to support their digital technology compliance team with computer systems lifecycle management and IT quality processes. The role involves ensuring the integrity and compliance of computerized systems within a highly regulated environment.

• Write, review, and approve validation and qualification deliverables within the electronic document management system.
• Ensure compliance with internal SOPs and external regulations including GxP, SOx, and Data Privacy.
• Deliver project validation and qualification requirements consistently and within specified timelines.
• Assist in the development and review of validation and qualification SOPs and templates.
• Resolve computerized system validation compliance issues and manage quality events such as CAPAs, deviations, and change controls.
• Maintain effective and open communication with stakeholders across quality, data engineering, and security domains.

• You have a Master or Bachelor in Computer Science, Life Sciences, or Engineering.
• You bring 8+ years of experience as a Validation Consultant or Quality Manager for computer systems within the pharmaceutical or biotech industry.
• You possess expert knowledge of regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, GAMP5, and CSA.
• You have extensive experience with the qualification of infrastructure and cloud platforms such as Azure, AWS, or OCI.
• You bring hands-on experience with cloud data warehouses like Snowflake or Databricks, data visualization tools such as Tableau or Power BI, and AI governance for LLMs.
• You’re a proactive communicator with a critical mind, high attention to detail, and a pragmatic approach to problem-solving.
• You are fluent in English.

Nice to Haves

• Experience with Veeva, ERP, QMS, ServiceNow, or Jira.
• Proficiency with the latest versions of the MS Office software package.