Senior QA Professional for Equipment Validation

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Kalundborg

Are you interested in joining an excellent team and be part of ensuring a quality in a high pace environment? Are you willing to use your quality-oriented mindset and excellent interpersonal skills to contribute to a significant impact on Quality Assurance? Do you strive when working in projects and with a large degree of autonomy? If yes, there is a challenging and exciting job opportunity in Product Supply Aseptic Manufacturing Quality Assurance (PS AM QA) in Kalundborg, and you could be the Senior QA professional that we are seeking – read more and apply! The Position As a Senior QA Professional, you will be involved in one or more projects, working closely with production colleagues and stakeholders to ensure the highest quality in validating and qualification of existing and new equipment. In this role your main responsibilities will be:
  • Setting direction regarding validation and qualification activities and documentation

  • Review and approve Science and Risk based Validation documentation

  • Perform oversight of both equipment suppliers and on-site

  • Ensuring compliance with current GMP rules and guidelines and to maintain product quality

  • We are in beautiful Kalundborg and have a great office environment with sparring and casual atmosphere. Due to our close collaboration with an ongoing production, the work is mostly carried out on-site, with room for working from home days, depending on the project you will be assigned to. Moreover, [xxxxx] encourages its employees to take ownership of their work and make a significant impact on the organization. As a Senior QA Validations Professional, your achievements will have a significant impact on Quality Assurance, and you will be a critical asset to the team and could potentially become the QA lead on some projects. Qualifications To succeed in this role, you:
  • Hold a masters’ degree in the natural sciences

  • Have several years’ of experience in QA role, preferably within equipment validation

  • Have gained said experience in the pharmaceutical or medical devices industry

  • Are fully proficient in English

  • On a personal level, you have excellent skills in collaborating with stakeholders from different cultures and organisational levels, and you thrive in a dynamic environment where cooperation with many different stakeholders will be crucial to your success. Furthermore, you work systematically, logically, and proactively. About the Department PS AM QA KA is responsible for the Aseptic Manufacturing facility in Kalundborg, which produces haemophilia and growth hormone products, with more in the pipeline. We are tasked with ensuring compliance with the ever-evolving complex requirements and regulations in the aseptic guidelines. We have excellent collaboration within the department and with other production sites 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. 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 QA Manager Kenneth Højer +[xxxxx]. Deadline  3 September 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 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 Kalundborg.

    Jobbet er oprettet på vores service den 20.8.2024, 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.
    • 20.08.2024
    • Øvrige
    • Kalundborg

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