- Ensure all aspect of Kyowa Kirin's Quality Management Systems (QMS) are applied to medicinal product distribution activities:
- Actively contributes to activities under the responsibility of the GDP Responsible Person, the Designated Person for API and the QP for distribution of Drug Substance(s)/Drug Product(s)/Finished Product(s)/QP Certified Finished Product(s).
- Execute supplier and customer verification management (e.g., onboarding/offboarding, contractor risk assessment, Bona Fide and Quality Technical agreement(s)).
- Executes Quality Assurance of Stock management (e.g., QA oversight of Inbound/Outbound, non-conformities, returns, stock reconciliation and destruction) with no delay to QA in close contact/cooperation with internal (e.g. SC/ finance) & external stakeholders (3PL(s)/customer(s))
- Drives the monitoring of the distribution contractors' quality performance according to a set of defined metrics with periodic reporting and proposes actions/improvement where applicable.
- Drives continuous improvement activities of the established QMS to support continuous compliance with the established licences.
- Executes implementation of Kyowa Kirin QA Global Policies and Global/Regional Procedures/Documents relevant to distribution activities.
- Ensure prompt and professional communication (including proposals for steps forward) of key issues to senior management as required to ensure effective collaboration towards compliant resolution of issues relating to licence compliance, supply and distribution of product.
- Actively participates in project management meetings to ensure the progress of ongoing tasks and to recognize and rectify any deficiencies in distribution-related activities
- Lead internal & contributes to external audits to assess adherence to GMP/GDP/GDP-API product distribution requirements and Kyowa Kirin QA Policies/Procedures.
- Raises appropriate change controls following quality risk management principles to ensure the change is compliant with applicable distribution/supply GDP/GMP regulations and the related QMS policies and procedures.
- leads investigations of distribution/supply non-conformities, deviations and temperature excursions and ensure appropriate CAPA are identified and implemented.
- Work closely with relevant stakeholders internally and externally:
- Internally e.g., members of cross functional groups in Kyowa Kirin as appropriate (e.g., Supply Chain, Project Management, Regulatory Affairs, Pharmacovigilance, Medical and Business)
- Externally e.g., GDP contractors/service providers in the territory.
- Deliver training to staff, as required.
- Degree in life science or equivalent with preference of a minimum of 3 to 5 years' experience in GDP.
- Specialist knowledge and experience of pharmaceutical QMS processes and practices.
- Experience of working within the pharmaceutical industry operating in a Quality Assurance position at a manufacturing/distribution site.
- Excellent working knowledge of GDPs for the distribution of commercial medicinal products
- Effectively working with cross-functional teams at a local and regional level.
- Good technical writing and editing skills.
- Fluent in English language and good level of Dutch - both verbal and written.
- As this can be a sedentary position the individual needs to be able to withstand long periods of sitting.
- Ability to use VDU equipment, read and focus intently for long periods of time.
- A degree of flexibility needed with regards to rare occasions where working late/early might be required.
- Limited travelling (local and international) might be needed for internal/external meetings.
- Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
- Takes responsibility for ensuring key deliverables.
- Good interpersonal and communication skills.
- Good analytical and problem-solving skills.
- Team working.
- Self-starter with a good eye for detail and ability to complete tasks/objectives.
- Ability to operate in a "virtual" pharmaceutical environment.
-
Logistics Specialist
Gevonden in: Talent NL C2 - 2 dagen geleden
allnex Duivendrecht, NederlandWaarom zijn we trots op wat we doen bij allnex? Wij creëren coatings, producten die helpen de wereld te beschermen voor de generaties na ons – en dat is precies wat jij kan doen door je bij ons aan te sluiten · Stel je voor hoe snel je smartphone bekrast raakt, lelijk zou worden ...
-
Customer Logistics Specialist
Gevonden in: Talent NL C2 - 3 dagen geleden
The Kraft Heinz Company Amsterdam, Nederland VoltijdDescription · Over de positie · Kom jij het verschil maken bij Kraft Heinz? Wij hebben een mooie, tijdelijke kans voor een Nederlands-sprekende Customer Logistics Specialist De functie valt binnen de lokale Benelux business unit en rapporteert aan de Customer Excellence Lead. He ...
-
Logistics Specialist
Gevonden in: Talent NL C2 - 5 dagen geleden
Page Personnel Amsterdam, NederlandWe are seeking a logistics assistant who primarily supports the transportation/logistics team: · Collecting documents from the DMS tool for outbound shipments; · Preparing cargo documents as per (import) requirements of the project countries, share relevant documents on Share-Poi ...
-
Junior Logistics Specialist
Gevonden in: Adzuna NL C2 - 6 dagen geleden
Randstad Amsterdam-Duivendrecht, NederlandFunctieomschrijving · Are you someone with a bit of experience within logistics and want a job where you can grow? If you have previous experience in logistics, you are fluent in English, and you are looking for a new challenge to play a crucial role in optimizing our supply chai ...
-
Junior Logistics Specialist
Gevonden in: beBee S2 NL - 2 dagen geleden
Randstad AMSTERDAM-DUIVENDRECHT, Nederland VoltijdAre you someone with a bit of experience within logistics and want a job where you can grow? If you have previous experience in logistics, you are fluent in English, and you are looking for a new challenge to play a crucial role in optimizing our supply chain operations, then thi ...
-
Logistic support specialist
Gevonden in: Talent NL C2 - 2 dagen geleden
Canon Amstelveen, Nederland Voltijd Fixed TermCompany information Canon is the world's best imaging company and a leading global brand – driven to enrich people's lives and businesses with innovative products and smart digital solutions. We are an international company that values diversity & inclusion by being respectful, s ...
-
Logistics Specialist
Gevonden in: Talent NL C2 - 1 dag geleden
Delta Electronics Hoofddorp, Nederland VoltijdJob Description · We are looking for an experienced Logistics Specialist to audit internal processes and external 3rd party warehouse providers. We are selling industrial electronics product. The market is EMEA (Europe, Middle East and Africa). We have sales offices and represent ...
-
Logistics Specialist
Gevonden in: Talent NL C2 - 1 dag geleden
Delta Electronics Hoofddorp, Nederland VoltijdJob Description · • Monitor and analyze sales forecast on SAP/EDI systems and through regular review meetings with customers, logistic partners, and Business Units · • Prepare sales reports for monthly business reviews · • Support cross business group / business unit accounts and ...
-
Logistics Specialist
Gevonden in: Talent NL C2 - 6 dagen geleden
International Flavors & Fragrances Oegstgeest, NederlandJob Description · Are you passionate about service excellence in logistics operations? Would you love to work for a global organization that is doing more good for people and planet? · IFF is a global leader in food, beverage, health, biosciences and sensorial experiences. We ar ...
-
Logistics Specialist
Gevonden in: beBee S2 NL - 6 dagen geleden
IFF Family of Companies Oegstgeest, NederlandJob Description · Are you passionate about service excellence in logistics operations? Would you love to work for a global organization that is doing more good for people and planet? · IFF is a global leader in food, beverage, health, biosciences and sensorial experiences. We are ...
-
Team Logistics Specialist
Gevonden in: Talent NL C2 - 6 dagen geleden
Nouryon Amersfoort, NederlandThe Team Logistics Specialist is responsible for completion of daily end to end international shipment activities for the region. · Are you a Logistic Specialist with experience in all aspects of shipping and delivery and ensure customer satisfaction by staying in contact and re ...
-
Logistics Supervisor- Part Time
Gevonden in: Jooble NL O C2 - 6 dagen geleden
Randstad Amsterdam, Nederland Voltijd, DeeltijdAre you someone with a bit of experience within logistics and want a job where you can grow? If you have previous experience in logistics, you are fluent in English, and you are looking for a new challenge to play a crucial role in optimizing our supply chain operations, then thi ...
-
Senior IT Consultant
Gevonden in: Recruitics US D C2 - 5 dagen geleden
Boston Consulting Group Amsterdam, NederlandWho We Are · Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transfor ...
-
Fachinformatiker/in,2nd-Level-Supporter/in
Gevonden in: Talent BE 2 C2 - 23 uur geleden
Universitätsklinikum Düsseldorf Medical Services GmbH(UKM) Amsterdam, Nederland2nd-Level-Support, Hardware, ITIL, Softwareentwicklung,IT-Infrastruktur, IT-Support, Scanner, IT Professional work in an exciting and modernenvironment: Universitätsklinikum Düsseldorf Medical Services GmbH(UKM) is one of four wholly-owned subsidiaries of the UniversityHospital D ...
-
Manager Logistic
Gevonden in: Jooble NL O C2 - 1 dag geleden
HENKEL Amsterdam, NederlandAt Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging the status quo, join our community of over 50,000 pioneers around the globe. Our teams at Henkel Consumer ...
-
Transport Planner Amsterdam
Gevonden in: Appcast UK C C2 - 2 dagen geleden
ATC Computer Transport & Logistics Amsterdam, Nederland VoltijdATC is a European logistics, white glove, and technical services specialist for data centres. Our focus is on anticipating the · critical needs of our clients and delivering industry-leading standards for safety, security and reliability. Since being · established in 1979, we h ...
-
Sales Manager
Gevonden in: Jooble NL O C2 - 7 uur geleden
Adams Multilingual Recruitment Amsterdam, Nederland VoltijdThey're looking for a sales support specialist to join the support team of 5 people. In this role, you will provide support to the European Sales Team in Amsterdam, ensuring that the full range of services is provided to the customers. If you have 2+ years of experience in sales ...
-
Senior Project Engineer
Gevonden in: Jooble NL O C2 - 6 dagen geleden
NewCold Advanced Logistics NederlandThis is NewCold · NewCold is service provider in cold chain logistics with a focus on thedevelopment and operation of large, highly automated cold stores. NewColdstrives to be crucial in the cold chain of leading food companies, by offeringadvanced logistic services worldwide. W ...
-
Direct Transport CX Consultant
Gevonden in: Jooble NL O C2 - 6 dagen geleden
Damco Spain SL NederlandNo matter your dreams and ambitions, Maersk offers exciting career opportunities in a truly international working environment. When you join Maersk, the world becomes your workplace. You will feel the diversity and dynamics of our international business from day one. We commit to ...
-
Warehouse Manager
Gevonden in: Jooble NL O C2 - 6 dagen geleden
DP World NederlandDP World is eagerly seeking a skilled Warehouse Manager to join our dynamic team in Tilburg . If you're passionate about logistics and ready to take on a managerial role in a thriving environment, this opportunity is for you. Come be a part of DP World's innovative journey i ...
Senior QA Logistics Specialist - Amsterdam, Nederland - Kyowa Kirin
Beschrijving
Overview
Responsible for the following Territories: Licences established in the Netherlands with supply and distribution into the EMEA region as well as import and export activities.
Youparticipate in the compliance with GDP/GDP-API & GMP requirements for the distribution of Medicinal Product (e.g., Drug Substance/Drug Product/Finished Product/QP Certified Finished Product) into the EMEA region as well as import and export activities.
Responsibilities
Qualifications
Physical Requirements: (travel, lifting, typing, driving, sitting, special requirements around hours etc.)
Key Competencies specific to the role: (what traits or capabilities must they have to succeed, examples include presentation skills, attention to detail, capability to influence and negotiate).
Options
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Kyowa Kirin International is an equal opportunities employer. If you require any additional support through the interview process, you can raise this in complete confidence. Software Powered by iCIMS