CSV Lead

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique MSI Pharma Temps plein
Join a reputable company based in Belgium and contribute to its ongoing success in the dynamic field of Biotechnology.

This opportunity offers a freelance contract with the initial assignment extending until the end of December, with the possibility of an extension.

The role is hybrid, providing flexibility in work arrangements.

Key Responsibilities:

  • Lead timely execution of Periodic Review exercises in collaboration with stakeholders such as ITSO, PDO, and Compliance.
  • Manage defects in alignment with stakeholders and oversee PRR review, comments, and approval processes.
  • Escalate issues to the Compliance Lead when necessary.
  • Perform validation activities and deliverables on Changes and small Projects.
  • Develop test scripts (IQ/OQ), support the creation of PQ (on business processes), develop protocols, and prepare reports.
  • Be fully available and committed during Inspection/Audit preparation and defense.
  • Participate in weekly activities review meetings with the associated Compliance Lead.
  • Provide direct reports to the Compliance Lead on personal activities via biweekly meetings.

Experience Required:

  • Minimum 3 years of experience in CSV on various projects in related scopes, specifically in Manufacturing (PCS, Scada, MES), and Laboratory (Standalone, Lab equipment, Excel files).
  • Involvement with GMP, GDP, and/or GLP projects.
  • Excellent proficiency in English; French would be a bonus.
  • Strong testing knowledge.

If you are available at short notice and possess the required skills, please send your resume as soon as possible for immediate feedback.

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