Site Transfer Coordinator

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Hillerød

Do you thrive working with regulations and documentations? Would you like to use your strong stakeholder skills and attention to details to coordinate transfer activities and deliverables into production? Then apply today as you might be the Site Transfer Coordinator we are looking for. The position As Site Transfer Coordinator, you will be coordinating projects related to the implementation of the production of medical devices/drug-device combination products and co-pack into a production site, which could be both internally or externally within our Contract Manufacturing Organisations (CMOs). Your main responsibilities include:
  • Coordinating transfer activities and deliverables into production, including preliminary discussions with subject matter experts (SMEs) to agree on impact and necessary activities (Specifications, analytical method validation, manufacturing control strategy, training, stability studies, regulatory submissions and process validation strategy)
  • Establishing deadlines for deliverables with stakeholders and following up to ensure execution in project management systems/tools
  • Managing documentation related to transfers, such as change requests, transfer plans, and reports, in accordance with Good Manufacturing Practice (GMP) validated systems
  • Presenting transfer results/reports to authorities and during inspections/audits, providing explanations of decisions made and the rationale behind them
  • Working according to Standard Operating Procedures (SOPs) and regulations, creating and maintaining documentation to meet internal and external requirements
  • Being responsible for escalations and the point of contact for the manufacturing site regarding the site transfer project
    • Qualifications To be considered for this position, we imagine you:
  • Hold at least a bachelor’s degree in engineering or any other relevant field
  • Possess a previous experience working in Quality Control (QC), Quality Assurance (QA) or production/manufacturing (production assistant, shift coordinator, etc) for example
  • Have already worked in a regulated industry (such as pharmaceutical, medical devices, food, energy industries)
  • Are fluent in English, both written and spoken
    • It would be considered as an advantage if you have a previous experience as project coordinator. As a person, you enjoy working with regulations and documentations. You are detail-oriented and possess strong coordination and communication skills. You thrive in working in an international environment and dealing with a broad variety of stakeholders, both internally and externally. Last but not least, you are self-driven and know how to navigate in a complex organisation. About the department The position is in Device Development division which is part of [xxxxx] Device & Manufacturing Development (DMD) department. Device Development holds the design responsibility for [xxxxx]’s medical devices and delivery systems and is the ManDev link between Device R&D and production. In Device Development, the main task is to maintain marketed products as well as develop new variants of existing product platforms and transfer them into manufacturing sites. Our deliverables have direct impact on our ability to deliver to the market, on patient safety, and on compliance with the requirements of the authorities. You will join our Portfolio Strategy and Process team of dedicated professionals, who work to ensure efficient and effective transfer of products into production. Our department plays a crucial role in maintaining compliance with regulations and meeting the needs of stakeholders. The atmosphere is fast-paced and dynamic, with a focus on collaboration and continuous improvement. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
    Contact
    For further information, please contact Eleonora Bertelli, Site Transfer Coordinator, at +[xxxxx]or Henrik Rasmussen, Senior Manager Portfolio Strategy & Process, at +[xxxxx].
    Deadline
    25 April 2024. Please note that applications will be reviewed on an ongoing basis, therefore we encourage you to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Hillerød.

    Jobbet er oprettet på vores service den 11.4.2024, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 11.04.2024
    • Øvrige
    • Hillerød
    Rapportér

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