Charleroi Metropolitan Area
Product Design Owner in Nutrition portfolio. Incubator to raise innovation mindset, as early adopter and mentor.
Support product development as Design Quality Manager. Main projects: fish oil emulsion, change of primary film, change labeling, process transfer, nitrosamines remediation in nutrition portfolio. Incubator early adopter to raise adaptability and innovation mindset.
Animation du Club Dispositif Médical au CQHN. Rencontre entre professionnel du Medical Device.
Main projects: - QMS in compliance with ISO13485:2016, MDR and MDSAP. - Technical file for CE submission - Implementation of electronic documentation management - Implementation of electronic management for QMS processes (CAPA, NC, Changes, ...) - Quality Control Management, Test Method Validation - QC Team creation and management Process Validation * Equipment operational (OQ) and performance qualification (PQ) * Process validation PPQ (sterilization process, manufacturing processes) and Quality control definition based on results. * Test Method Validation OPERATIONAL QA: - Manage NCs, CAPA and Change controls QMS (Quality Management System) Management: * Maintain and continuously improve Quality System processes SOPs required by authorities and standards * Support and conduct formal Management Review meetings and follow-up Product Design and Development and Product Validation * Product and Process Specifications definition * Be responsible, with the support of engineering and manufacturing, for the establishment of design and development plans/ product; the appropriate execution and documentation of design control activities (e.g. Design Inputs, Design Outputs, Design Verification); the review and approval of relevant documentation. * Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of Product Design Inputs/product further product development. Order Processing and Manufacturing * Be responsible for materials and suppliers evaluation and approval; materials and products release and traceability (including materials and product release) Product Release * Has responsibility and authority for intermediate and final product release (equivalent to QP in pharma) Audits and monitoring * Establish and analyze key performance indicators to evaluate and continuously improve the QMS * Manage internal and external audits
QMS (Quality Management System) Management: * Be responsible for establishing in approved documents, maintain and continuously improve Quality System processes required by international, regional and national regulatory authorities and standards * Prepare and conduct formal Management Review meetings and follow-up Product Design and Development and Product and Process validation *Be responsible, with the support of engineering and manufacturing, for the establishment of design and development plans/ product or process validation; the appropriate execution and documentation of design control activities (e.g. Design Inputs, Design Outputs, Design Verification)/ validation activities; the review and approval of relevant documentation. * Provide engineering and manufacturing with the relevant quality and regulatory affairs requirements that are part of Product Design Inputs/product or process validations further product development. Order Processing and Manufacturing * Be responsible for materials and suppliers evaluation and approval; materials and products release and traceability (including materials and product release) Product Release * Has responsibility and authority for intermediate and final product release (equivalent to QP in pharma) Post Market Surveillance – Product Monitoring * Establish and follow-up Product Monitoring through - Complaints - Post Market Product Evaluation - Materiovigilance System and Resource Monitoring * Establish and analyze key performance indicators to evaluate and continuously improve the QMS * Manage audits (internal and external) * Be responsible for regulatory intelligence and update QMS accordingly Resources Management * Be responsible for HR induction program and ongoing training process
GSK has an aseptic single use system department. These single use systems are used for vaccines production. This job consisted as: conception of single use systems with the collaboration of suppliers and other GSK departments (quality, manufacturing, validation). RESPONSIBILITIES: O Defining specifications based on users needs O Preparing testing protocol and report to qualify each single use system (DOE, IQ, OQ, PQ) O Organizing and performing testing O Project management