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CSV Lead (Compliance)

CSV Lead (Compliance)

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CSV Lead (Compliance)

  • Location:

    Brussels

  • Sector:

    Technical Operations - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Interim/Contract

  • Contact email:

    glenf@msipharma.com

  • Job ref:

    VR/04699_1707219793

  • Published:

    22 days ago

  • Duration:

    9 Months +

  • Startdate:

    ASAP

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.