GxP Validation Lead for AI, Cloud & Data Platforms

Planet Pharma; Belgique; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Planet Pharma is seeking an experienced Validation Consultant to support the validation and compliance of critical digital systems, cloud platforms, and AI-driven solutions within a fast-paced life sciences environment.

You will collaborate with Quality, Data Engineering, Product, and Security teams to drive compliance, validation excellence, and risk-based decision making across a diverse technology landscape.

Qualifications

• Significant experience in Validation/CSV in regulated industries.
• Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, Data Integrity and risk-based validation methodologies.
• Strong experience validating cloud-based infrastructure and platforms (Azure, AWS, Oracle Cloud).
• Hands‑on experience with modern data environments (Snowflake, Databricks, Tableau, Power BI).
• Experience validating AI solutions (Generative AI, LLMs) in regulated settings.
• Proven ability to collaborate with Quality, Data, Product, and Security stakeholders.
• Excellent documentation skills and attention to detail.
• Self‑sufficient, pragmatic, autonomous work style.

Responsabilités

• Author, review, and approve validation and qualification documentation
• Support computer system lifecycle management activities
• Ensure compliance with GxP, SOx, Data Privacy, Cybersecurity and regulatory requirements
• Apply GAMP 5, CSA, and Data Integrity frameworks
• Manage and maintain Change Controls, Deviations, CAPAs, and Risk Assessments
• Develop and improve validation procedures, SOPs, and templates
• Identify and resolve compliance issues and project risks
• Collaborate with cross-functional stakeholders to ensure timely delivery of validation activities

Connaissances

Validation Consultant experience

CSV Specialist

IT Quality professional

GxP Compliance knowledge

Formation

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

Outils

Veeva

ServiceNow

Jira

ERP

QMS

Description du poste

Planet Pharma is seeking an experienced Validation Consultant to support the validation and compliance of critical digital systems, cloud platforms, and AI-driven solutions within a fast-paced life sciences environment.

You will collaborate with Quality, Data Engineering, Product, and Security teams to drive compliance, validation excellence, and risk-based decision making across a diverse technology landscape.