Quality Assurance Professional - Primary Packaging

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Hillerød

Do you have the purpose of being The Ambassador for millions of patients around the world by safeguarding their safety? Are you a solution-oriented person with a passion for Quality Assurance? Do you get inspired by using quality as an active driver of Primary Packaging development projects? If yes, then you might be the person we are looking for in Devices & Delivery Solutions Quality in Hillerød, Denmark. Apply now for our Quality Assurance Professional job opportunity focused on Primary Packaging!
The position In this position, we are looking for a candidate to provide quality oversight to primary packaging for Drug Device Combination Products and for Drug Products in the development portfolio of Devices & Delivery Solutions in Novo Nordisk. As Quality Assurance Professional, you play a very important role where you work with many different stakeholders both internally in Novo Nordisk, and with outsourced development partners. The right candidate will be part of the primary packaging development process from early innovation until launch, give input to project planning, and ensure project deliverables at each development phase. Core responsibilities include:
  • Quality oversight of the primary packaging development process.
  • Reviews and approves development documentation regulated by GxP requirements.
  • Handling most situations independently, apply your subject matter knowledge and identify better practice and drive improvements to Quality Assurance processes.
  • Playing an active role in sharing knowledge and learnings and thereby letting your colleagues learn and shine.
  • Providing active assistance during authority inspections and internal audits, both in the practical setup and in backing the projects in presenting documentation.
    • Our Quality Assurance Professional will be responsible for facilitating our development projects in setting direction for quality in terms of internal and external requirements. This is achieved both proactively by supporting the projects in making the right approach to quality, and by reviewing and approving design control documents. The ability to find the best way of achieving both quality and other project objectives, and to set a clear direction is a key responsibility as a Quality Assurance Professional. Qualifications To fulfil the role, you have:
  • A pharmaceutical, chemical, engineering, or other relevant academic degree with a strong quality mindset.
  • Experience from the pharmaceutical industry.
  • Track record of interpreting regulatory requirements and preferably well versed in regulatory requirements and standards such as: EU GMP - part I, II, III and IV, 21 CFR 210/211/820; 21 CFR part 4; Ph Eur, USP.
  • Fluent in both written and spoken English on a professional level.
  • Experience in active participation and leading audits is an advantage.
    • In addition, some of your strengths are to constructively engage your stakeholders and navigate in cross organisational stakeholder landscapes. You have ability to quickly understand situations and dilemmas and are solution oriented in introducing innovation within procedural and regulatory constraints along with translating regulatory guidance into operational practice to furtherance the development of devices. Clear communication and use of facts to present your point of view when needed to ensure regulatory compliance or patient safety is highly required, as well as being able to notice when our processes can be improved and have the drive to make change happen. About the department Devices & Delivery Solutions Quality is accountable for covering all quality aspects in the development portfolio of primary packaging, mechanical devices, devices with embedded electronics and software, and software as a medical device, as well as projects investigating new paradigms for drug delivery. Further, we work on Quality Management System activities, quality oversight of our suppliers, and host inspections. We are an international team of 30 passionate Quality Assurance experts with diverse backgrounds of which the vast majority is based in Hillerød, Denmark - and a small part of the Device R&D located in USA. Along with the rest of the device development area, we have a high focus on patients and take pride in having a significant impact on the life of patients by ensuring high quality, safe, and effective products. Working at Novo Nordisk At Novo Nordisk, 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 If you have any questions about the job, please do not hesitate to call Dean Kloe, Quality Senior Manager at +45 3075 8948. Deadline 07 January 2024. 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 Novo Nordisk 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.


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    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 11.12.2023, men kan have været deaktiveret og genaktiveret igen.

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