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Xellia Pharmaceuticals is owned by Novo A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark. Xellia has global facilities in Europe, North -America, and Asia, currently employing over 1500 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.

Corporate QA Specialist

    We are looking for a QA specialist (Global Quality Process Owner) to the corporate Quality Systems and Projects team. The team is responsible for the Quality Manual and its global procedures that are used on our sites around the world. We are also managing some of the global Quality IT systems as well as the corporate Training.
    You will be based in Budapest, with some travel required.

What should you do?

    As Quality Specialist, you will be acting as global business process owner for some of our Quality processes, for example Quality Risk Management, Process Validation, Calibration and others.

    In this role you would:
    • Deliver Quality process improvement activities, update procedures and its implementation
    • Designs and creates Quality process training materials; develop roll-out plans to all sites
    • Create, implement & deliver a Quality process improvement plans, including improvements to supporting GxP IT systems if required
    • Identify, define & implement appropriate measures of Quality process performance
    • Collect the data needed to measure & manage Quality process performance
    • Establish and/or lead a Quality process or sub-process core team with guidance.
    • Understand how relevant GxP IT systems support / enable the business process
    • Participate in Health Authority / customer audits and inspections globally as subject matter expert (support)

Who are you working with?

    In the team you will be working with 12 colleagues located in Budapest, Copenhagen, Raleigh, Cleveland and Oslo that share the passion for pharma Quality Management systems and process management and their GxP IT systems. As process owner you will have a network of Quality specialist in our sites globally, where you together with them define the improvements areas for the Quality processes. For processes that are supported by GxP IT systems you will also work in close collaboration with the system developers located in various locations around the world.

What do we expect from you?

    You have relevant academic degree, fluent in spoken and written English and you are performance and solution oriented with collaborative mindset. You should have a good understanding of pharmaceutical quality management processes with relevant work experience. Candidates with previous experience in global pharma working and business process management will be preferred.

Sector(s):

  • Engineer
  • Quality Assurance Engineer
  • Healthcare, Pharmaceutical Industry
  • Quality Assurance
  • Manufacturing, Production
  • Quality Assurance
  • Full time

Experience required:

  • 1-3 years professional experience

Required language level:

  • English - higher advanced/fit for negotiation

Job location:

Budapest, X. district

Apply:

To apply for this position, please send both your English and Hungarian CV.
To apply you have to push the „apply” button, what you can find below.
Please, also include your salary expectation.
Potential candidates will be confirmed, only!

A hirdetés adatai:
  • Pozíció neve: Corporate QA Specialist
  • Rövid pozíció név: Minőségbiztosítási szakember
  • Hirdető cég: XELLIA Gyógyszervegyészeti Kft.
  • Elsődleges kategória:
  • Terület: Budapest
  • Város: X. kerület
  • Feladatok: As Quality Specialist, you will be acting as global business process owner for some of our Quality processes, for example Quality Risk Management, Process Validation, Calibration and others.In this role you would: Deliver Quality process improvement activities, update procedures and its implementation Designs and creates Quality process training materials; develop roll-out plans to all sites Create, implement & deliver a Quality process improvement plans, including improvements to supporting GxP IT systems if required Identify, define & implement appropriate measures of Quality process performance Collect the data needed to measure & manage Quality process performance Establish and/or lead a Quality process or sub-process core team with guidance. Understand how relevant GxP IT systems support / enable the business process Participate in Health Authority / customer audits and inspections globally as subject matter expert (support)
  • Elvárások: You have relevant academic degree, fluent in spoken and written English and you are performance and solution oriented with collaborative mindset. You should have a good understanding of pharmaceutical quality management processes with relevant work experience. Candidates with previous experience in global pharma working and business process management will be preferred.
  • Elvárt végzettség: Főiskola
  • Elvárt nyelvismeret: Angol
  • Foglalkoztatás jellege: Teljes munkaidő
  • Szükséges tapasztalat: 1-3 év szakmai tapasztalat
  • Feladás dátuma: 2018-02-13
Állás, munka még: XELLIA Gyógyszervegyészeti Kft.>