QMS Specialist/Expert - Synthetic APIs (oligo, peptide, small molecules)

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Are you curious to use your quality knowledge, experience and mindset in an exciting organization and are you familiarized with synthetic API development and production? Would you enjoy being responsible for setting the quality agenda for synthetic API’s? Then, we invite you to explore this exciting opportunity at [xxxxx].Read more and apply for a life-changing career with us today!The positionIn this multi-faceted role, you will establish and chair QMS process groups for chemical synthetic APIs and support the yearly planning of quality activities across departments.Additionally, you will ensure that the right quality procedures and training are in place at corporate and department levels, implementing regulatory requirements, and drive maintenance and improvement activities. You will act as an expert for interpretation on quality subjects and support the organization for audits and inspections to ensure overall inspection readiness.Your main tasks will include:
  • Managing quality processes for synthetic intermediates and APIs as NN Process Manager or QMS specialist.
  • Ensuring quality procedures, regulatory requirements and training are implemented across the organization.
  • Driving maintenance and continuous improvement activities for the synthetic intermediates and API quality process.
  • Establishing and leading process groups for synthetic intermediates and APIs.
  • Supporting audits and inspections to ensure the overall inspection readiness.
    • This job gives you a unique opportunity to work with multiple stakeholders, highly skilled scientists and the entire GMP network both locally and on a globally level.QualificationsWe are looking for a person with:
  • An academic degree as a Pharmacist, Chemist, Engineer, Scientist, or similar discipline.
  • Knowledge within organic chemistry.
  • Extensive experience from the pharmaceutical industry, in roles related to QMS, manufacturing or QA.
  • Strong understanding of ISO standards, GMP, GxP regulations and requirements.
  • Experience with project management, and preferable are Lean certified.
    • In addition to these, you need to be fully proficient in both spoken and written English.On a personal level you thrive and get motivated by working with and across all levels in the organization, whilst you enjoy great collaboration and communication and setting direction. Additionally, you are solution oriented and work systematically with a pragmatic approach and strive for simplicity in processes.About the departmentAs a part of [xxxxx]’s Product Supply organization, you will be assigned to our Emerging Technologies (ET) API MSAT (Manufacturing Science and Technology) department. We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management.We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.The department is newly established presenting a unique opportunity to join at the beginning of an exciting journey, while benefiting from the established way of working in [xxxxx]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. Working at [xxxxx], we’re working toward something bigger than ourselves, and it’s a collective effort. Join us! Together, we go further. Together, we’re life changing.ContactFor further information, please contact Kirsten Bisgaard-Frantzen, Manager at: +[xxxxx]Deadline21 April 2025Applications 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 [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.


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    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 1.4.2025, 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.
    • 01.04.2025
    • Øvrige
    • Bagsværd
    Rapportér

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