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Pharmacovigilance and Regulatory Affairs Manager BeNeLux

KYOWA KIRIN LIMITED

Amsterdam

A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. * Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary - Responsible for the management and oversight of the pharmacovigilance system and activities for the company. Post-licensing regulatory activities associated with ensuring that all Kyowa Kirin International's marketed products in the BeNeLux countries are in compliance with applicable legislation and business requirements. * The local registered person for the Netherlands, and local persons are registered for Belgium and Luxembourg; ensure the regular monitoring of the regulatory authority websites * Collaborate with local Medical Affairs and KK Global PV, to implement local Risk Minimisation commitments A combined role for covering Pharmacovigilance (PV) and Regulatory Affairs (RA) for the BeNeLux countries. * Provision of local regulatory advice and support to HQ Regulatory Affairs, cross-functional teams, affiliates and partners, as necessary - Responsible for the management and oversight of the pharmacovigilance system and activities for the company. Post-licensing regulatory activities associated with ensuring that all Kyowa Kirin International's marketed products in the BeNeLux countries are in compliance with applicable legislation and business requirements. * The local registered person for the Netherlands, and local persons are registered for Belgium and Luxembourg; ensure the regular monitoring of the regulatory authority websites * Collaborate with local Medical Affairs and KK Global PV, to implement local Risk Minimisation commitments
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Regional Quality Engineer (EMEA)

Corning Optical Communications GmbH & Co. KG

Amsterdam

Support quality complaint resolution for CLS business in the EMEA Region (Europe, Middle East, and Africa) with a focus on improving Key Account customer satisfaction. * Support EMEA Business Quality and Regulatory Lead improvement initiatives related to processes, systems, and product/service quality measures. * Responsible for being aware of division quality initatives and procedures. * Responsbile for woking with plant quality function as a liason with EMEA commercial and business operations organization, by identifying and implementing effective communication processes and feedback channels. * Monitor complaint trends in EMEA, if necessary, need to escalated to regional business team for development of both short and long term corrective actions. * Closure of Quality Helpdesk tickets for EMEA region * Meet the objectives of the Regions, Quality Function's and Division's Vital Few Support quality complaint resolution for CLS business in the EMEA Region (Europe, Middle East, and Africa) with a focus on improving Key Account customer satisfaction. * Support EMEA Business Quality and Regulatory Lead improvement initiatives related to processes, systems, and product/service quality measures. * Responsible for being aware of division quality initatives and procedures. * Responsbile for woking with plant quality function as a liason with EMEA commercial and business operations organization, by identifying and implementing effective communication processes and feedback channels. * Monitor complaint trends in EMEA, if necessary, need to escalated to regional business team for development of both short and long term corrective actions. * Closure of Quality Helpdesk tickets for EMEA region * Meet the objectives of the Regions, Quality Function's and Division's Vital Few
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Senior Quality Assurance Officer

MSD LIMITED

Haarlem

Je hebt deze ervaring opgedaan als Quality Assurance Officer, Quality Release Officer of vergelijkbaar en je hebt ervaring met GMP; Quality Assurance Onze Quality Assurance afdeling zorgt ervoor dat al onze producten worden geproduceerd, verwerkt, getest, verpakt, opgeslagen en gedistribueerd volgens zeer hoge kwaliteitsnormen en de geldende regels en wetten. Het Quality Release Specialties team ondersteunt de gehele Haarlem site met betrekking tot de quality assurance en quality release activiteiten van verschillende producten, en de introductie van nieuwe producten op de markt. * Quality Assurance verantwoordelijkheden voor een aantal producten. Voor het Center of Excellence (CoE) Quality in Haarlem zijn wij op zoek naar een - Binnen de Quality Release afdeling, bestaat de sub-afdeling Quality Release Specialties. Je hebt deze ervaring opgedaan als Quality Assurance Officer, Quality Release Officer of vergelijkbaar en je hebt ervaring met GMP; Quality Assurance Onze Quality Assurance afdeling zorgt ervoor dat al onze producten worden geproduceerd, verwerkt, getest, verpakt, opgeslagen en gedistribueerd volgens zeer hoge kwaliteitsnormen en de geldende regels en wetten. Het Quality Release Specialties team ondersteunt de gehele Haarlem site met betrekking tot de quality assurance en quality release activiteiten van verschillende producten, en de introductie van nieuwe producten op de markt. * Quality Assurance verantwoordelijkheden voor een aantal producten. Voor het Center of Excellence (CoE) Quality in Haarlem zijn wij op zoek naar een - Binnen de Quality Release afdeling, bestaat de sub-afdeling Quality Release Specialties.
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Pre-Assembly Project Manager

MHI Vestas Offshore Wind A/S

Amsterdam

Consequently, close cooperation and alignment with the Project Manager and relevant sub-contracted companies is a vital part of the position. Do you want to make your mark on large-scale pre-assembly projects? Are you a skilled project and stakeholder manager with a soft spot for game-changing green solutions? …focus on our pre-assembly projects in the APAC region, or more specifically, Taiwan and Japan. Here you will ensure the progress of the pre-assembly project according to time, and implement optimising processes where needed. It is your overall responsibility to ensure timely delivery of the pre-assembly project while staying within the budget. * Managing and leading the Pre-Assembly team * Engaging the Pre-Assembly team in continuous improvement processes * Ensuring effective HSE and Quality Management within the Pre-Assembly site Consequently, close cooperation and alignment with the Project Manager and relevant sub-contracted companies is a vital part of the position. Do you want to make your mark on large-scale pre-assembly projects? Are you a skilled project and stakeholder manager with a soft spot for game-changing green solutions? …focus on our pre-assembly projects in the APAC region, or more specifically, Taiwan and Japan. Here you will ensure the progress of the pre-assembly project according to time, and implement optimising processes where needed. It is your overall responsibility to ensure timely delivery of the pre-assembly project while staying within the budget. * Managing and leading the Pre-Assembly team * Engaging the Pre-Assembly team in continuous improvement processes * Ensuring effective HSE and Quality Management within the Pre-Assembly site
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Supplier Quality Engineer

MSD LIMITED

Haarlem

The supplier quality engineer is responsible for serving as a primary point of contact for high risk and escalated suppliers for our company sites. We have an exciting opportunity in Haarlem for a Supplier Quality Engineer (secondary packaging). The Quality Engineer will be assigned to either the Glass, Primary Packaging, Secondary Packaging, Product categories, but will provide cross-over support to all the categories, as needed. Exercise leadership in monitoring and maintaining supplier compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), our Quality Manuals, Quality Management Systems (QMS), and pertinent legal and/or business contract requirements. Leading supplier deviation investigations, upskilling suppliers for Quality, Compliance and Regulatory improvements, and interfacing with our sites. The supplier quality engineer is responsible for serving as a primary point of contact for high risk and escalated suppliers for our company sites. We have an exciting opportunity in Haarlem for a Supplier Quality Engineer (secondary packaging). The Quality Engineer will be assigned to either the Glass, Primary Packaging, Secondary Packaging, Product categories, but will provide cross-over support to all the categories, as needed. Exercise leadership in monitoring and maintaining supplier compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), our Quality Manuals, Quality Management Systems (QMS), and pertinent legal and/or business contract requirements. Leading supplier deviation investigations, upskilling suppliers for Quality, Compliance and Regulatory improvements, and interfacing with our sites.
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Teamleider Engineering

Lekkerkerker Groep

Lopik

Wat ga je doen als Teamleider Engineering We voegen de afdelingen engineering & electra per 2021 samen en zijn op zoek een stevige teamleider. Trefwoorden: manager engineering, manager techniek, teamleider techniek, electrical engineering, vacature elektrotechniek, vacature werktuigbouwkunde - Je team bestaat uit een mix van 12 ervaren en minder ervaren mechanical-, electrical,- en software engineers van diverse leeftijden, die staan voor hun vak. Aan jou de taak om het team te versterken en verder te professionaliseren en samen onze projecten tot een succes te brengen. De focus ligt op het optimaliseren van engineering- en elektraprocessen en sturen op de meest efficiënte en rendabele uitvoering. De afdeling Engineering & Electra maakt onderdeel uit van Operations. Wat ga je doen als Teamleider Engineering We voegen de afdelingen engineering & electra per 2021 samen en zijn op zoek een stevige teamleider. Trefwoorden: manager engineering, manager techniek, teamleider techniek, electrical engineering, vacature elektrotechniek, vacature werktuigbouwkunde - Je team bestaat uit een mix van 12 ervaren en minder ervaren mechanical-, electrical,- en software engineers van diverse leeftijden, die staan voor hun vak. Aan jou de taak om het team te versterken en verder te professionaliseren en samen onze projecten tot een succes te brengen. De focus ligt op het optimaliseren van engineering- en elektraprocessen en sturen op de meest efficiënte en rendabele uitvoering. De afdeling Engineering & Electra maakt onderdeel uit van Operations.
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Product Engineer Emobility

Vattenfall

Amsterdam

We are looking for a Product Engineer Connected Chargepoint Hardware! The Product Engineer will Hardware Network. * Provide technical consultancy & 'on demand hardware analyses' for product developers * Create a clear profile towards customers through distinguishing charging products and services - You will be responsible for the analysis, implementation and portfolio – focusing on quality & technology – supporting the Strategy & Product Development team. * Manage all technical communications with charge station hardware suppliers and sub-contractors regarding existing and future products & features. * , new hardware products, and internal electrical components of the charging stations/accessories – via hands-on electrical measurements and benchmarking. We are looking for a Product Engineer Connected Chargepoint Hardware! The Product Engineer will Hardware Network. * Provide technical consultancy & 'on demand hardware analyses' for product developers * Create a clear profile towards customers through distinguishing charging products and services - You will be responsible for the analysis, implementation and portfolio – focusing on quality & technology – supporting the Strategy & Product Development team. * Manage all technical communications with charge station hardware suppliers and sub-contractors regarding existing and future products & features. * , new hardware products, and internal electrical components of the charging stations/accessories – via hands-on electrical measurements and benchmarking.
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Field Service Technician

Innio

Friesland / Noord Holland

De installaties worden ondersteund met service tijdens hun hele levensduur. Op zoek een nieuwe uitdaging als Service Monteur? Innio * Friesland / Noord Holland * Tijdelijk werk, interim, projectbasis * Fulltime - Wie zijn wij? Jenbacher Gas Engines producteert gasgestookte zuigermotoren, generatorsets, warmtekrachtkoppelingen en toebehoren voor energieopwekking en compressors. Stuk voor stuk dragen die bij aan een efficiëntere en goedkopere energie opwekking op locatie. Onze motoren een vermogensbereik van 330 kW tot 10 MW werken op een flexibele reeks brandstoffen, waaronder aardgas, maar evengoed biogas, stortgas, mijngas, rioolgas en industriële afvalgassen. Onder andere met bewaking en diagnose van afstand. De fabriek van Jenbacher Gas Engines, een onderdeel van INNIO, is gevestigd in Jenbach, Oostenrijk. Jouw verantwoordelijkheden - Elke dag afwisselende werkzaamheden, op een andere werklocatie? De installaties worden ondersteund met service tijdens hun hele levensduur. Op zoek een nieuwe uitdaging als Service Monteur? Innio * Friesland / Noord Holland * Tijdelijk werk, interim, projectbasis * Fulltime - Wie zijn wij? Jenbacher Gas Engines producteert gasgestookte zuigermotoren, generatorsets, warmtekrachtkoppelingen en toebehoren voor energieopwekking en compressors. Stuk voor stuk dragen die bij aan een efficiëntere en goedkopere energie opwekking op locatie. Onze motoren een vermogensbereik van 330 kW tot 10 MW werken op een flexibele reeks brandstoffen, waaronder aardgas, maar evengoed biogas, stortgas, mijngas, rioolgas en industriële afvalgassen. Onder andere met bewaking en diagnose van afstand. De fabriek van Jenbacher Gas Engines, een onderdeel van INNIO, is gevestigd in Jenbach, Oostenrijk. Jouw verantwoordelijkheden - Elke dag afwisselende werkzaamheden, op een andere werklocatie?
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Projectleider Gevel - en Serrebouw

Solarlux Nederland BV

Nijverdal

Hij/zij neemt actief deel aan bouwvergaderingen werkoverleg en scholingen - Solarlux Nederland BV * Nijverdal * Vast contract, onbepaalde tijd * Fulltime - Introductie - Adembenemende uitzichten en ruimtes met een unieke woonbeleving – daar staat Solarlux al 35 jaar voor. Als specialist van hoogwaardige flexibele geveloplossingen zoeken wij persoonlijkheden, die zich prettig voelen in een dynamische en vooruitstrevende werkomgeving en ons team versterken met passie, team geest en creativiteit. Jouw werkzaamheden * Het voorbereiden, plannen, inmeten, bewaken en opleveren van opdrachten met montage zowel bij individuele opdrachten als bij projecten * Het adviseren bij en het meewerken aan het tot stand komen van projectmatige opdrachten * Het adviseren, inmeten en instructie geven bij door klanten zelf uit te voeren montages * Het werven, inplannen en controleren van montagebedrijven Hij/zij neemt actief deel aan bouwvergaderingen werkoverleg en scholingen - Solarlux Nederland BV * Nijverdal * Vast contract, onbepaalde tijd * Fulltime - Introductie - Adembenemende uitzichten en ruimtes met een unieke woonbeleving – daar staat Solarlux al 35 jaar voor. Als specialist van hoogwaardige flexibele geveloplossingen zoeken wij persoonlijkheden, die zich prettig voelen in een dynamische en vooruitstrevende werkomgeving en ons team versterken met passie, team geest en creativiteit. Jouw werkzaamheden * Het voorbereiden, plannen, inmeten, bewaken en opleveren van opdrachten met montage zowel bij individuele opdrachten als bij projecten * Het adviseren bij en het meewerken aan het tot stand komen van projectmatige opdrachten * Het adviseren, inmeten en instructie geven bij door klanten zelf uit te voeren montages * Het werven, inplannen en controleren van montagebedrijven
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Technical Logistics Engineer

Siemens Gamesa Renewable Energy B.V.

Hamburg

Lastly the technical logistics engineer will be involved in technical support to logistics project execution and incident handling. * The technical logistics engineer will support the sales organization with technical due diligence and route surveys. * Thereafter the technical logistics engineer will be engaged in technical due diligence and supplier qualification of heavy haulage trucking suppliers, port handling operators and stevedoring suppliers. * You have an educational background as a Logistics Engineer with a min. 5+ years relevant experience. Do you want to be a part of a global team specialized within logistics and transportation of our Windmills and turbines? The logistics department consists of 4 high-performance teams. Lastly the technical logistics engineer will be involved in technical support to logistics project execution and incident handling. * The technical logistics engineer will support the sales organization with technical due diligence and route surveys. * Thereafter the technical logistics engineer will be engaged in technical due diligence and supplier qualification of heavy haulage trucking suppliers, port handling operators and stevedoring suppliers. * You have an educational background as a Logistics Engineer with a min. 5+ years relevant experience. Do you want to be a part of a global team specialized within logistics and transportation of our Windmills and turbines? The logistics department consists of 4 high-performance teams.
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Full Stack Engineer

Searchability

Amersfoort

Searchability * Amersfoort * Vast contract, onbepaalde tijd * Fulltime - Fantastic opportunity to join the best technical organisation utrecht has to offer! Based in our amazing offices in the heart of Amersfoort, we are a collective of talented professionals who are all self-motivated to provide the best technical solutions that our clients won't find anywhere else in the Netherlands. If you're looking for a new role that is going to give you opportunities to progress yourself and your technical skill set, look no further! What will you be doing? * Becoming a key part of our close-knit Scrum team, becoming the sixth member, you will be heavily involved with producing excellent projects with; PHP (Zend/Symfony/Laravel), JavaScript (Vue/Angular/React) and other tools. Searchability * Amersfoort * Vast contract, onbepaalde tijd * Fulltime - Fantastic opportunity to join the best technical organisation utrecht has to offer! Based in our amazing offices in the heart of Amersfoort, we are a collective of talented professionals who are all self-motivated to provide the best technical solutions that our clients won't find anywhere else in the Netherlands. If you're looking for a new role that is going to give you opportunities to progress yourself and your technical skill set, look no further! What will you be doing? * Becoming a key part of our close-knit Scrum team, becoming the sixth member, you will be heavily involved with producing excellent projects with; PHP (Zend/Symfony/Laravel), JavaScript (Vue/Angular/React) and other tools.
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Workshop Engineer

Tetra Pak

Lopik

At our workshop in Lopik we are looking for a Workshop engineer. The Workshop Engineer functionally of the Workshop and officially reports to the FSO Team Leader. You will be responsible for the implementation of specialized maintenance, repair, bowl balancing and modification tasks on the equipment sent to the workshop by our customers (mainly separators). Tetra Pak * Lopik * Vast contract, onbepaalde tijd * Fulltime - At Tetra Pak we touch millions of lives every day, ensuring better nutrition and healthier lifestyles through safe packaging and food processing solutions. Guided by our global brand promise, PROTECTS WHAT'S GOOD, we strive to make a difference by protecting food, people and our futures. To do this we need more than smart technology. We need smart people too. People like you, who want to work with people like us. Your responsibilities At our workshop in Lopik we are looking for a Workshop engineer. The Workshop Engineer functionally of the Workshop and officially reports to the FSO Team Leader. You will be responsible for the implementation of specialized maintenance, repair, bowl balancing and modification tasks on the equipment sent to the workshop by our customers (mainly separators). Tetra Pak * Lopik * Vast contract, onbepaalde tijd * Fulltime - At Tetra Pak we touch millions of lives every day, ensuring better nutrition and healthier lifestyles through safe packaging and food processing solutions. Guided by our global brand promise, PROTECTS WHAT'S GOOD, we strive to make a difference by protecting food, people and our futures. To do this we need more than smart technology. We need smart people too. People like you, who want to work with people like us. Your responsibilities
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