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Data Integrity & CSV Specialist (Remediation Lead) - LIMS

Digital
Data
Advanced (5+)
Location
Braine-l'Alleud, Walloon Brabant
Work type
Consultancy
Work model
Fulltime, Hybrid

Our client, a leading pharmaceutical company, is seeking an experienced professional to lead and execute a global data integrity remediation plan. This role focuses on strengthening the framework for a global system through strategic coordination and hands-on technical execution within a regulated environment.

Responsibilities

  • Lead the execution of a comprehensive remediation plan comprising approximately forty high-priority actions.
  • Define action items, owners, and timelines while coordinating remediation activities across multiple cross-functional teams.
  • Define and implement a global SOP for routine and periodic Audit Trail Reviews.
  • Perform comprehensive reviews of user roles, system privileges, and access rights justifications to identify corrective actions.
  • Conduct Data Integrity Risk Assessments and develop detailed Data Flow Diagrams.
  • Organize and facilitate workshops with stakeholders to drive issue resolution and ensure project completion.
  • Monitor progress against the remediation roadmap and provide regular status reporting to stakeholders.

Requirements

  • You possess 5+ years of experience in Data Integrity and CSV including regulatory expectations, Risk Assessments, and Data Flow Diagrams.
  • You bring experience in leading remediation programs and executing Audit Trail Reviews and SOP implementation.
  • You have knowledge of user roles, privilege matrices, and access management.
  • You're a strong communicator with the ability to collaborate across multiple teams and departments.
  • You are fluent in English.

Nice to Haves

  • Experience supporting global LIMS environments or hands-on experience with LabWare.
  • Experience managing inspection observations and remediation activities in multi-site organizations.
  • Working knowledge of French.

Offer

  • Enjoy a competitive salary package with extra perks that recognize your talent.
  • Advance your career with a clear growth path, coaching, and mentoring to support you.
  • Thrive in a dynamic and supportive environment where you can truly make an impact.
  • Work when and where you perform best, ensuring an optimal work-life balance.
  • Choose a flexible transport solution, from a company car to a public transport subscription.
  • Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
  • Grow your skills with external courses and our in-house Pauwels Academy.
  • Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
  • Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
# 103153
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