GMP Coordinator

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Kalundborg

Would you like to have a central role at our BRD filling and packaging factories? Do you enjoy building deep insight and knowledge within GMP by securing the right quality mindset, creating structures, and preparing us for future audits inspections? If that sounds like the greatest job, then the role of GMP coordinator for our site in Kalundborg might be a good fit. Apply now and join us! The Position As our GMP coordinator you will be working to ensure a high level of quality and compliance from our newly established department by setting the right standards in maintaining our Quality Management System (QMS), so that we continuously deliver on all relevant GMP requirements. You will be collaborating closely with many great colleagues within the department and in the factories, and you will be part of a great GMP Coordinator network, where you will have good GMP colleagues to spare with. You will be assigned as a GMP coordinator for a specific department in the factories. You will be responsible for:
  • Ensuring high-level GMP overview and report quality trends to management
  • Supporting daily operations and ensure the relevant level of GMP in our factory
  • Driving preparation for and follow-up on authority inspections and internal audits
  • Leading and coordinating critical quality issues and compliance activities in the department and across the factory.
  • Working in the Quality Management System – Delivery to Quality Management Review (QMR).
    • Furthermore, you will participate when we are involved in audits and inspections. Qualifications To succeed in this role, you have:
  • Minimum a bachelor' degree in pharmacy, biochemistry, production engineering or similar or several years of experience in the pharmaceutical industry with GMP.
  • A strong understanding of GMP regulations and requirements.
  • Excellent communication and interpersonal skills.
  • Full proficiency oral and written English. Danish is highly advantageous.
    • On a professional level you have the ability to work independently with a pragmatic mindset whilst you are capable of managing multiple projects and priorities. On a personal level, you thrive on working with individuals at all levels of the organization. You enjoy collaborating and communicating with others and setting a clear direction. You are solution-oriented and work systematically with a pragmatic approach, always striving for simplicity in processes. About the department Our newly established department Operational Excellence (OpEx) is working to ensure operational compliance with the QMS system, strengthen our license to operate, continue to develop and deploy the cLEAN Supply System, and provide excellent training to our colleagues within our CVP area. You will be a part of the OpEx support team with other GMP coordinators and supporters, a total of 13 colleagues. The OpEx department also consists of the Training & Archive Support team and the cLean Support team and is supporting 7 different departments in two factories. Working at BRD, 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. 3000 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 If you want to know more about the position, please contact Associate Manager Kamalan Ratnasingham at +45-30777842. Deadline 25 February 2024. Applications will be screened on an ongoing basis, so you are encouraged 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.


    Information og data

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

    Arbejdsstedet er beliggende i Kalundborg.

    Jobbet er oprettet på vores service den 9.2.2024, 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.
    • Øvrige
    • Kalundborg
    Rapportér

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