IT Validation Lead

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We are looking for a skilled IT Validation Lead to help drive the digital transformation of [xxxxx] and lead our validation and compliance efforts in LABS department. In [xxxxx], we have a passion for improving patients’ lives all over the world. Will you help us bringing that passion to life? Would you like to further develop your expertise within validation and quality control? Then apply now! Skills we are looking for
  • Proven and extensive experience within validation of IT systems, preferably from the pharma industry (GxP), or other regulated industries
  • Experience working with large scale projects and validation, preferably in an agile manner
  • Good communication and facilitation skills
  • Fluent in spoken and written English
  • As a person you are curious, up to date with latest technologies, proactive, and you thrive in a challenging, dynamic, and ever- changing environment,. You have quality mindset with good ability to execute within deadlines. When collaborating you are open minded, positive, and confident. In addition, you must have strong work ethic and willingness to take responsibility and drive success. Role waiting for you This is a job for those who are excited to work with technologies, validation, testing and quality control in agile IT projects. As a IT Validation Lead you will be responsible for defining the strategy, planning and reporting of validation, in relation to a specific implementation, integration, or upgrade of an IT systems with GxP (healthcare) impact. You will work closely with the product owners, Line of Business (LoB) and other stakeholders to understand the scope of validation and act as liaison with LoB QA and ITQA. Your key responsibilities will include:
  • Execution of validation and quality control activities: Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, reporting, and ensuring that these are executed effectively.Helping develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing
  • Conducting assessments such as IT risk assessment, Supplier Assessment etc., and facilitating the workshops for these activities: Ensuringvalidated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in cooperation with the system managers and IT responsible when needed
  • Participating in audits and inspections and then finding solutions to identified compliance gaps: Ensuring that systems follow relevant internal and external regulatory requirements. Ensuring the data integrity and security requirements of IT system have been met and may work with systems include GDPR/Confidentiality data
  • Supporting development teams in creation and maintenance of test plans, test scripts and user acceptance tests: Managing the execution of test plans. Supporting overall validation approaches in different teams/Projects in the LABS department, and suggest improvements
  • Team waiting for you
    LABS is a part of Digital Data & IT Product Supply (DD&IT PS) organisation which has approx. 850 employees based in Denmark, India, US, China, France and Brazil. The strategic objective of the unit is to be the IT partner for the business, ensuring that we provide the IT solutions and support to the [xxxxx] production solution as well as supply chain needs worldwide. In LABS you will be part of a highly engaged department developing and improving IT systems which are core to the laboratory processes in [xxxxx]. Though you will be working with a lot of colleagues from around the globe, the job location will be in Denmark.
    Join [xxxxx] family Do you want to support IT Solutions that make a difference? Merge your operational skills with our global impact and help us drive digital transformation with a purpose. Learn more on TechLife at [xxxxx] . [xxxxx] is the leading pharmaceutical company within diabetes, located in the Copenhagen area. At Novo Nordisk, we use our skills, dedication, and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to contribute to patient care on a global scale. From research and development to manufacturing, marketing, and sales – we are all working to make a difference.
    Contact
    For further information, please contact Lilian Juma Lausen +[xxxxx] Deadline
    5 November 2024 Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified. 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. 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 Ballerup.

    Jobbet er oprettet på vores service den 16.10.2024, 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.
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