GMP Coordinator

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Gentofte

Are you passionate about compliance, structure, and continuous improvements? Are you self-motivated, structured and have an efficient nature, and do you have the ability to see solutions in a broader perspective? Then you are the candidate we are looking for! The Position As our new GMP Partner you will be working to ensure a high level of quality and compliance in our Aseptic Filling department in Gentofte, by setting high standards in maintaining our Quality Management System (QMS), through ensuring that the department continuously deliver on all relevant GMP requirements by ensuring and improving quality mindset. You will be working closely with many colleagues within the department but also across departments, including QA. You will be responsible for:
  • Driving preparation for and follow-up on authority inspections and internal audits
  • Ensuring high-level GMP overview and report quality trends to management
  • Leading and coordinating critical quality issues and compliance activities in the department and across if necessary.
  • Working in the Quality Management System – Delivery to Quality Management Review (QMR).
  • Supporting daily operations and ensure a high level of GMP in the department as well as
  • Supporting and run deviations and change requests if necessary.
    • As part of your responsibilities, you will also run smaller compliance projects in the department and conduct the training of new employees in GMP. Qualifications To succeed in this role, you have:
  • A bachelor or master’s degree in sciences such as pharmacy, biochemistry, or production engineering or similar
  • Solid experience with GMP, compliance and documentation
  • Full proficiency in both English and Danish.
  • Experience with lean is an advantage, as it is an integrated part of operations
    • On a personal level you thrive and get motivated by working with and across all levels in the organisation, whilst you are known for your excellent collaboration and communication skills and ability to set direction. You are solution oriented and work systematically, proactively and strive for simplicity in processes, while taking pride in solving your tasks and challenges as close to the process as possible, with close involvement of your stakeholders. About the Department Our team is part of the BRD Finished Products Gentofte and Vaarloese area that is the production site situated close to Copenhagen. Here we are app. 620 colleagues who take responsibility for transforming Active Pharmaceutical Ingredients into the finished product that patients can use all over the world. We are producing at full speed on existing lines while building and ramping up new state of the art facilities. Our complex processes require a high level of expertise, commitment, and engagement from our employees and include formulation, filling, freeze-drying, product inspection, assembly and pack. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with LEAN and always looking for improvements within our processes, but also in the way we work together to make our products reach as many patients as possible Working at Novo Nordisk Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career? Contact To learn more about this opportunity please call, Senior Project Manager, Cecilie Moberg on +45 34 48 12 42. Deadline 5 November 2023. Interviews will be held throughout the period, and 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 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 Gentofte.

    Jobbet er oprettet på vores service den 11.5.2023, men kan have været deaktiveret og genaktiveret igen.

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