Requirements: English
Company: CareerWallet
Region: Braine-l''Alleud , Wallonia
Contracting Brabant Wallon Primary packaging systems innovation and new products development management : New primary packaging systems development management in line with the strategy, Pipeline Devices & Delivery Systems and technologic/scientific platforms objectives and according to established working processes. Clinical medical devices design and assessment Primary packaging systems life cycle & sustaining management : Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO''s. Competitors pharmaceuticals primary packaging systems benchmarking management : Competitors primary packaging systems portfolio analyze & characterization. Primary packaging materials, components and technology scouting and assessment according to defined priorities Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies. Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures Proven track record in project management / Project Management certification will be a distinct advantage Fluency in French & English Jefferson Wells offers you a permanent contra... Benchmarking, Pharmaceuticals, Innovation, Platforms, GMP, Documentation, Maintenance, Delivery, Waste Disposal, Scouting, Biopharmaceuticals, ISO13485, Law, Projects, Packaging materials, Technology, Regulation, Pharmaceuticals, Practicality, Training, Planning, ISO 14971, Pipelines, Raw material, Organization Skills, VOS, Accident prevention, Project Management, Waste Disposal, GMP, Emergency Services, Management, Landscaping, Global Projects, Legislation, Training Sessions, International law, Packaging, Characterization, Project Management, Medical Devices, Development Process, Conferences, Science, Packaging Industry, System Life Cycle, Implementation Originele vacature is te vinden op StepStone.be Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carriretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d''emploi est disponible sur stepstone.be Crez maintenant votre Job Agent sur StepStone et trouvez le job de vos rves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrire sur stepstone.be! CRWL1_BE