QA Professional with interest in Computerized Systems and Global Collaboration
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Hørsholm
For this exciting position we are looking for a recently graduated M.Sc in Health/Natural Sciences with interest in working with quality in the department Global Quality Clinical & Markets, covering areas of responsibility within GCP, GVP, GMP, GDP and Medical Devices.
In this position, your competencies and skills will come into play with focus on the process part of the many computerized systems that ALK is using in connection to clinical trials, pharmacovigilance, document management and training.
With your interest and flair for IT systems and processes, you will be in close contact with several head- quarter functions as well as close contact with the ALK Affiliates around the world as you will be their daily support during performance qualifications and roll out of electronical systems related to document management and training as a process QA. During daily operations you will be their trainer and Go-to person for sparring and problem solving.
Fields of responsibility
Your qualifications
Languages:
Travelling days:
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
27 April 2022
Contact
For further information on the position please contact Siren Jenssen Østerberg, Senior Director Global Quality Clinical & Markets, tlf: +45 5089 9540.
In this position, your competencies and skills will come into play with focus on the process part of the many computerized systems that ALK is using in connection to clinical trials, pharmacovigilance, document management and training.
With your interest and flair for IT systems and processes, you will be in close contact with several head- quarter functions as well as close contact with the ALK Affiliates around the world as you will be their daily support during performance qualifications and roll out of electronical systems related to document management and training as a process QA. During daily operations you will be their trainer and Go-to person for sparring and problem solving.
Fields of responsibility
- Approval of IT documentation related to performance qualification and validations of computerized systems e.g. user requirement specifications, performance qualification protocols and reports
- Daily support and training of the ALK affiliates needs in connection to document handling and training systems
Your qualifications
- M.Sc. in Health/Natural Sciences, Pharmacy or equivalent1+ years of experience within GxP regulated areas including experience with Quality Management Systems and tools
- Strong drive and interest in computerized systemRelation builder and team player, working respectfully across different cultures with flexibility
- Strong cross-cultural communication skills verbally as well as written. Produces written material that is clear, fluent and easy to understand
- Experience with qualification of computerized system processes is an advantage
- Proactive and takes initiative and actively seeks influence and initiates actions on own initiative
Languages:
- Fluent Danish and English (verbally and written).
Travelling days:
- Approximately 20 travelling days a year world-wide can be expected.
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
Application deadline
27 April 2022
Contact
For further information on the position please contact Siren Jenssen Østerberg, Senior Director Global Quality Clinical & Markets, tlf: +45 5089 9540.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 8.4.2022, 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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- Hørsholm
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