GMP Coordinator

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Hillerød

Are you well-versed in Good Manufacturing Practice (GMP) and driven by the challenge of setting high compliance standards while continuously improving processes? Do you have the ability to act as a role model within GMP? If yes, then you are the perfect fit for our GMP Coordinator position in Formulation & AP support in Hillerød, Denmark. Read on and apply below for this exciting opportunity at [xxxxx].

The Position
As a GMP Coordinator at [xxxxx] site in Hillerød you will be at the heart of a dynamic environment where no two days are similar. In this role you will be the driving force behind our commitment to excellence in the production of life chancing injectables products within diabetes and obesity. You will juggle coordination, follow-up, and strategic direction-setting, while pushing key actions and projects forward across the department. Your ability to stay flexible, prioritize effectively, and manage your time will be crucial as you balance these diverse responsibilities alongside your own tasks.

Your main responsibilities in this role will include:
  • Driving the preparation and overseeing the follow-up on authority inspections and internal audits
  • Collaborating with stakeholders to ensure implementation of requirements from authorities
  • Coaching and assisting your colleagues in GMP-related tasks such as deviations, validations, changes, projects etc.
  • Preparing trend reports, Quality Oversight Tools, Quality Management Reviews (QMR) and Quality Monitoring Trends (QMT)
  • Maintaining a high-level GMP overview and reporting on GMP and quality trends to management
  • Coordinate projects in the department and collaborate with relevant stakeholders, such as IT, QA and AMSAT
  • But that is not all – you will also be an essential member of the GMP network within the CVP area. Here, you will have the opportunity to foster collaboration, align goals, and share best practices. If you are energized by the prospect of making a broad impact while driving both team and individual success, this is the perfect role for you.

    Qualifications

    On a personal level, you are positive, action-oriented, and thrive in a cooperative environment. You approach challenges with a solution-focused attitude, working systematically and proactively. Your communication skills enable you to connect with everyone from operators to management as well as other departments. You are proud of your ability to tackle tasks hands-on, ensuring that the key stakeholders are engaged and involved throughout the process.



    To excel as our GMP Coordinator we expect you to have:
  • A BSc or MSc degree in pharmacy, biology, engineering, or a related field
  • Minimum three years of experience in process support or QA in the pharmaceutical, medical device or similar regulated industry
  • Strong experience and skills in GMP-regulated environments and complex production processes
  • Willingness to drive projects in the department
  • The ability to see the big picture while never losing sight of the critical details that make all the difference
  • A mindset which is rooted in LEAN principles, and experience in systematic problem-solving, always looking for ways to improve efficiency and effectiveness
  • Fluency in both Danish and English, allowing you to communicate seamlessly across our organization
  • About The Department


    Formulation & AP Support (Environmental Monitoring, Utility, Wash & Sterilisation and Formulation) is part of our filling factory in Hillerød, which is delivering life chancing injectable products within diabetes and obesity. We are a department of dedicated operators, skilled workers and supporters who are responsible for supplying our filling lines with product, equipment, materials and primary packaging. We work closely together, both across professional boundaries and departments, to deliver with a very high level of quality to our patients. The team consist of 5 formulation professionals, one GMP coordinator, one local training coordinator and 2 student assistants.

    Working at [xxxxx]
    [xxxxx] Product Supply Finished Production Manufacturing is a global production network at the forefront of technology and quality production of pharmaceutical products, supplying all [xxxxx] products to people living with serious chronic diseases. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology.ContactIf you have further question, please reach out to Associate Manager Maria Lysgaard at [xxxxx] April 2025You 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 4.4.2025, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 04.04.2025
    • Øvrige
    • Hillerød

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