Neuchâtel, Neuchâtel, Switzerland
Responsible of EM strategy and improvement plan for Fill/Finishing area (grade A, B, C, D area).
- Quality Oversight representative to ensure respect of Quality systems, GMP and regulatory requirements - Aseptic process periodic requalification (Media Fill) - Change Control: raise, review and evaluate changes requests according to procedures, GMP and licenses - Deviations: assess events in term of acceptability to procedures, GMP and regulatory requirements - Batch Release - Participate to internal and external audits: inspection of GMP areas, presentation in inspection room - Continuous Improvement: successful implementation of improvement projects; QA partner for the Continuous Improvement Team of the manufacturing units
Shire is now part of Takeda. QA Operational Expert for : - Fill and Finishing activities (Formulation, Aseptic Filling, Lyophilisation, Capping, Intermediate Packaging). - Utilities. - Warehouse.
Traveler for 6 months in the following countries : Thailand, Cambodia, Vietnam, Australia, New Zealand, Chile, Argentina.
Site Conformance Specialist for secondary operations (formulation, filling, packaging) - Provide CMC (Chemical, Manufacturing and Controls) expertise within the Belgium industrial organization to ensure continuous alignment of operations and the licences - QA single point of contact between manufacturing operations and Regulatory Affairs - Site support: ensure accuracy of source documents, approve on behalf of manufacturing operations files submitted to Authorities, coordinate questions & answers and provide technical support to Regulatory Affairs - Change Control: permanent member of the change control board. Perform the initial assessment of the potential regulatory & quality impact of changes, define appropriate strategy - Deviations: perform the release and regulatory impact of major deviations and propose remediation strategies - Empowered to develop and drive improvements of the regulatory conformance matters in GSK practices - Provide CMC and regulatory expertise to support the release of products - Certified trainer: CMC and QA trainings given to manufacturing operations - Manage capacity management tool and KPIs within the Site Conformance team
CRO (Nalys) - Redaction of technical sections (CMC) of a new Marketing Authorization Dossier - Answering of technical questions from Health Authorities (Europe, Japan) with the support of industrial operations
Apprenticeship - Member of a project team working in close interaction with European Supply Chain - Quality Assurance: Redaction of working instructions - Lifecycle management: Regulatory activities (coordination and interaction with Health Authorities)