QA Validation Specialist in Fill & Finish

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Gentofte

Would you like to be part of an exciting innovation journey implementing new assembly and packaging lines worldwide at Novo Nordisk? Do you have a strong quality mind-set and great interpersonal skills to make a difference within Quality Assurance? Then there is a challenging job opportunity in Fill & Finish Expansions FP QA in Gentofte. The position As QA Validation specialist in Fill & Finish Expansions FP QA you will set the direction for quality assurance, using SRV principles, in implementation of new assembly and packaging lines across the world. Your responsibilities will range from the early definition of requirements to the final handover to the local sites. You will have a role as Q-lead for one or more programs, where you will work closely together with several stakeholders across the world within DMD (Device Manufacturing Development), local implementation sites and local QA, to ensure implementation of new FP lines, with highest quality to patient in mind. As a part of the Q-lead role you will be setting direction, approving validation and qualification documentation and keeping oversight in relation to validation of the program. Other responsibilities include:
  • Ensuring compliance with internal and external quality requirements and regulatory requirements (cGMP)
  • Be an integrated part of creating, developing, and challenging the overall programme plan to ensure efficient and transparent systems, structures, and processes
  • Aligning with other areas within Fill & Finish Expansions FPto ensure clear interface and roles
  • Setting direction for the validation strategy in Fill & Finish Expansions FPand for the individual programs
    • Some international travel will be required. Qualifications
  • Master’s degree in Engineering, Chemistry, Pharmacy or similar
  • Minimum 5 years’ experience with validation or qualification, preferably as a QA person
  • Preferable experience working with Assembly and Packaging production
  • Experience with science and risk-based validation
  • Excellent skills in collaborating with stakeholders from different cultures and organisational levels
  • Strong quality mindset and result orientation
  • Proficiency in Danish and English, speaking and writing
    • As a person you are a team player, well organized and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirit high even when under pressure. You are a skilled communicator who can cooperate at any organizational level. About the department Fill & Finish Expansions FP QA is a newly established team as a part of Fill & Finish Expansions QA. We as Fill & Finish Expansions QA are playing a key part in major expansion projects with the aim of increasing the aseptic and finished production capacity across the Novo Nordisk network and to ensure we continue to deliver high quality products for our patients, also in the future. We want to rethink our way implementing aseptic and finished production and build something we can be proud of – also in 20 years from now. Our department is responsible for quality assurance and compliance of the new facilities. We ensure a high level of quality and compliance with GMP in close cooperation with our stakeholders. You will be a part of a team that works in a vibrant and positive working environment and values exchange of knowledge and experience. Networking and cooperation are key to our success. Contact For further information, please contact Senior QA Manager, Zlatko Hadzic at +45 30759697 or email [email protected]. Deadline Please submit your application no later than July 10th. Applications will be evaluated continuously, and candidates may be called for an interview before the deadline, so please apply as soon as you can. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Additionally, please avoid the use of photos in your CV. This provides a better and more fair process. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk 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 28.4.2023, men kan have været deaktiveret og genaktiveret igen.

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