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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