Qualified Person | Geleen

Key Responsibilities

• Release materials and final products for GMP processing, ensuring each batch has been manufactured and tested in full compliance with GMP requirements, applicable licenses, specifications, and clinical protocol amendments. Formally approve or reject final products and sign the relevant certification documentation as Qualified Person.

• Ensure continuous regulatory compliance, maintaining up-to-date knowledge of evolving regulatory requirements, guidelines, and industry standards, and ensuring these are reflected in operational and quality processes.

• Assess and approve investigations related to non-conformities and out-of-specification (OOS) results, ensuring root causes are properly identified and appropriate corrective and preventive actions (CAPAs) are implemented.

• Review and approve validation activities, ensuring validation strategies, documentation, and execution meet regulatory expectations and GMP standards.

• Lead and support internal and external audits, acting as a key quality representative during inspections and ensuring readiness for regulatory authority audits.

• Manage and oversee product recall activities when required, including initiating recalls and acting as the primary contact for local regulatory authorities and external stakeholders during recall procedures.

• Establish and manage quality agreements for assigned projects, ensuring clear responsibilities and compliance expectations between Lonza and external partners.

• Maintain and develop Qualified Person technical expertise, ensuring continuous professional development and maintaining up-to-date knowledge relevant to QP responsibilities.


NOTE: Project for 6 months (extension likely)

Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info.