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As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant. * Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones. * At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment * Strong Knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing
Good knowledge qualification and validation process, IT compliance, GMP knowledge, data Integrity principles
Ensure compliance of facilities and processes with regulatory standards (GMP Pharma). * Expertise in commissioning, qualification, and validation within a GMP framework.
Oversee the CPLO GMP activities and ensure all employees understand and follow all standard operating procedures. * Assist in ensuring inspection readiness, as well as participate in maintaining facility GMP compliance. * Assist management and in the writing of quality items such as Deviations, CAPA, Change Control, as well as writing of GMP documents relative to CPLO documentation to ensure compliance with all policies and procedures. * Excellent understanding in GMP related environment : at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality. * Proven and recognized expert in the field of GMP Compliance.
Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner * Maintain GMP compliance and inspection/audit readiness at all times. Operational GMP experience or clinical activities experience would be a distinct advantage.
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection. * Understands practical applications of GMP, compliance principles and theories including risk management
The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing * The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE). * Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines * Lead the GMP refresher project for CSC and Lab entities
Experience in the pharmaceutical industry and knowledge of GMP standards (a plus).
Knowledge of GMP (Good Manufacturing Practices) regulations.
Subject matter expert and trusted partner in a specific area of DS, DP or Analytical function working according to appropriate standards for quality (GMP, GSP and GLP), ethics, health, safety, environment, protection and IT; leading functional initiatives to ensure continuous improvement. * Up to date knowledge of GMP and regulatory requirements within area of expertise.
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