Project QA for Innovation & IT

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Gentofte

Want to combine your validation and IT skills with your passion for innovation and quality? Excited by setting the quality direction for cutting-edge aseptic technology projects implemented across multiple international sites? Ready to collaborate with experts, ensure compliance, and drive innovation in aseptic production? Then join us and make a global impact on medication quality, apply now! The position We are looking for a QA to support and set quality direction for technology and innovation projects within aseptic processes, across multiple international sites. By ensuring that quality is integrated into innovation projects from start to implementation at site we ensure that our lines are efficient and produce the best quality medication. In this project focused role, you will ensure that your projects live up to quality requirements, by early and continuous involvement and oversight, to set the right quality direction. The innovation and technology projects are focused on aseptic production lines, and surrounding processes, all of them being implemented across several lines and production sites. The solutions often require new IT systems, why you will set clear expectations for IT validations to ensure simple and functional IT integrations. You will spare and collaborate with project managers and team of experts and act as point of entry for QAs in the projects, to support a standardised implementation and operation at sites. With this role, we offer you an exciting, challenging, opportunity where you become part of a skilled team which acts as compliance sparring partners for our stakeholders, both locally and internationally. You will get great opportunities for both personal and professional development, with growing responsibility depending on your skills and interests. Qualifications We are looking for a colleague with the ability to set the right and balanced quality standards and ensure compliance within external requirements. To succeed in this role, you:
  • Hold a master’s degree in engineering, Biology, Chemistry, Pharmacy, or similar
  • Have several years of experience with IT and process validation
  • Have solid GMP experience from pharmaceutical industry
  • Have some experience/exposure to project work
  • Are fully proficient in English
    • On a personal level, you are self-driven, proactive, resourceful and thrive in a dynamic environment. Also, to support our international stakeholder landscape, you need skills setting up structures, alongside good communication and networking skills, to ensure simple and efficient Quality involvement. About the department You will become part of Aseptic Manufacturing Science and Technology QA, where we work to continuously improve and innovate our production processes, with many interfaces around the organisation, both in Denmark and our international production sites. The department consists of 55 people divided into four teams, supporting projects, aseptic product and process knowledge and QC laboratories. The department consists of highly knowledgeable and skilled people, covering the diverse area of AMSAT. In the department, we take great pride in our work and value challenges as opportunities. We have a vibrant and positive working environment, good values and exchange of knowledge and experience. We all work towards continuously improving our competences, as well as making work processes more efficient and effective. 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 Manager Andreas Dupont Rothemejer at +[xxxxx]. Deadline 24th February 2025 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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    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 4.12.2024, men kan have været deaktiveret og genaktiveret igen.

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