Quality Systems Specialist

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Do you want to use your skills to make good decisions, ensure regulatory compliance and validation within [xxxxx]? Are you always looking for continued improvements by challenging the status quo? If so, we now have an open position as Quality System Specialist in our digital validation system team, the TIMS Center of Excellence (CoE). Join us and apply today! The position The digital validation system, called TIMS (Test Information Management System), is based on ALM 12.5 and our team provides support to the validation process, the system owner and validation projects across [xxxxx], including guides, procedures, instructions, and training. As a Quality Systems Specialist and TIMS system architect you will be responsible for specifying and designing the best possible solution for digital validation and ensuring business and quality requirements. Other responsibilities include:
  • Support Process Expert for validation, Process Owner and Process Owner Delegate in managing the validation process with regards to digital validation.
  • Support NNQ management in improving the process of digitalization.
  • Ensure that current and new regulatory requirements are covered by the process.
  • Collaborate with key stakeholders in the line of business (LoB), QA, system group, and suppliers.
  • Manage and drive maintenance activities within the process in close collaboration with the IT System Manager.
    • Qualifications  We are seeking a Quality Systems Specialist with a strong quality mindset and experience with cross functional use of digital validation.
    To succeed in this role, you have:
  •    Academic degree within IT, pharmacy, engineering, or other related fields
  •    At least 5 years of experience from the pharmaceutical industry within IT, quality, or production
  •    Experience working with IT qualification and digital validation in a regulated environment (ALM)
  •    A flair for stakeholder management and networking at various organisational levels
  •   Strong communication skills, with proficiency in English
    • With your good cooperation and communication skills you can organize and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mindset and are a team player but are also able to work independently. You thrive on working across departments in an international organization. Great communication skills are a must. We are looking for a person who is team-oriented, self-driven, proactive, and responsible. The ideal candidate excels at collaborating and communicating, is solution-oriented, and demonstrates a strong commitment to actively cultivating a positive working environment. About the department The TIMS CoE is part of Investment Portfolio Quality Assurance, an area comprising around 250 highly skilled quality professionals who work to ensure early involvement in production facility investment projects, within the scope of the NN Investment Portfolio Committee. The primary objective of the TIMS CoE is to maintain, support, and develop the [xxxxx] Test and Validation Tool, which has over 10,000 active users. The tool is used for validation and testing of GxP-critical and non-critical IT systems and equipment in Global IT, Product Supply, and NNI. This role is based in Bagsværd. Working at [xxxxx] At [xxxxx], we don’t wait for change. We drive change. 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. Working at [xxxxx] is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing. Contact For further information, please contact Daniel S. Tranto at +[xxxxx]. Deadline 20 October 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.


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    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 2.10.2024, men kan have været deaktiveret og genaktiveret igen.

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