Senior Validation Team Leader
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Missions:
• Lead and coordinate the validation team, ensuring effective planning and execution of validation activities.
• Define and implement the validation strategy in accordance with GMP requirements and regulatory guidelines.
• Oversee process validation, cleaning validation, analytical method validation and computerized system validation, depending on project scope.
• Review and approve validation protocols, reports, risk assessments and technical documentation.
• Ensure compliance with GMP, regulatory standards and internal quality procedures.
• Supervise deviation investigations, CAPA implementation and change control processes.
• Coordinate cross-functional activities with QA, QC, Production, Engineering and Regulatory Affairs.
• Monitor project progress, timelines, resources and deliverables.
• Provide technical guidance, coaching and support to validation engineers.
• Act as the main point of contact for validation-related matters during audits and regulatory inspections.
• Drive continuous improvement initiatives and ensure the maintenance of the validated state. Background:
• Master’s degree in Engineering, Biotechnology, Chemistry, Pharmacy or a related scientific field.
• Minimum 5–8 years of experience in validation within the pharmaceutical or biopharmaceutical industry, including team leadership or project coordination experience.
• Strong expertise in validation strategy, lifecycle management and GMP compliance.
• Proven experience reviewing and approving validation documentation and managing complex validation projects.
• Excellent knowledge of deviation management, CAPA, change control and risk-based approaches.
• Demonstrated leadership, team management and stakeholder coordination skills.
• Ability to manage priorities, resources and multiple projects in a regulated environment.
• Fluency in French, English and/or Dutch is an asset. Contact: Roufaidaa.
EL-AMERI@akkodis.com Roufaidaa El Ameri Talent Acquisition Specialist
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