GMP & Validation Expert

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Kalundborg

[xxxxx] is investing DKK42 billion to expand its manufacturing facilities in Kalundborg to support its portfolio within chronic diseases. We're hiring a GMP & Validation Expert for this project. The activities will take place at our Kalundborg site, which is [xxxxx]'s hub for API manufacturing. Are you interested in being a part of a dynamic global company and working on an exciting new project for capacity expansion? This opportunity involves establishing new active pharmaceutical ingredients (API) manufacturing facilities that integrate new and automated technologies with strong expertise in biotech manufacturing.   Apply today and join us for a life-changing career!   The position As GMP & Validation expert (also called Project Quality Manager) you will be overall responsible for setting the quality direction for a new API production facility. Furthermore, you will:
  • participate in setting the direction on validation planning, design reviews, risk assessments, requirements for tests, qualification, and validation. A key design principle will be to copy existing design standards from other recent projects.

  • exercise strong leadership to keep the team focused on execution instead of comprehensive design considerations.

  • be an essential part of building a competent user organization, integrating with engineering partners, and collaborating with contractors while supervising their activities.

  • coordinate quality activities across the project and introduce newcomers to the [xxxxx] validation system, including the quality strategy, plans for design, qualification, and validation in the project.

  • be part of preparing overall quality documents within the project.


  • Qualifications To succeed in this role, you have:
  • 6 years+ of experience within GMP and pharmaceutical (API) manufacturing.

  • Master’s degree in pharmacy, chemistry, pharmaceutical process engineering, or similar.

  • experience working with validation and projects within the pharmaceutical industry.

  • English proficiency (verbal and written).

  • strong and impactful communication skills- including teaching skills, and high quality mindset – being able to balance requirements against the fast progress of project activities.

  • On a personal level, you enjoy teamwork and are a strong motivator of others. You thrive in a multicultural environment that demands independence to make critical decisions. Building structure comes naturally to you, and you enjoy simplifying wherever simplicity can benefit in reaching the right goals faster.
    About [xxxxx] Kalundborg
    At [xxxxx] Kalundborg, 3200 employees produce half of the world's insulin and several biopharmaceutical products. With over 50 years of experience in large-scale biotech manufacturing, it is the world's largest insulin-producing facility. Joining [xxxxx] Manufacturing in Kalundborg means a developing career, where you will be met with trust and responsibility by dedicated colleagues with diverse backgrounds in a successful company with a higher purpose and an inclusive environment. Together, we make a difference every day for over 42 million people living with diabetes and other chronic diseases.   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 Mie Boa Jacobsen (Senior Project Manager) at +[xxxxx].    Deadline
    18 August 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 CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.  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 Kalundborg.

    Jobbet er oprettet på vores service den 22.7.2024, 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.
    • Øvrige
    • Kalundborg

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