QA Professional with interest in becoming a Good Clinical Practices Auditor
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Hørsholm
Are you recently graduated or a have a few years' experience with interest in working with Good Clinical Practices/GCP?
Then come and join a great company which makes a difference for people with allergy!
We can offer a unique trainee position where your competencies and skills will come into play with focus on development to become a Lead Auditor performing GCP audits of Clinical Trial sites and CROs/suppliers.
As part of the auditor role, you will also act as the QA Business Partner for the Global Clinical Development area in ALK, handling suppliers, SOPs and WINS in ALK's quality management system and you will be involved in process optimizations in general.
We are looking for a new colleague to the department Global Quality Clinical & Markets, which consists of 10 colleagues in Headquarter working with GDP, GMP, GCP, GVP and Medical Devices.
Fields of responsibilities
QA Business Partner for the Global Clinical Development department.
Your preferred professional qualifications
Your personal 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.
Then come and join a great company which makes a difference for people with allergy!
We can offer a unique trainee position where your competencies and skills will come into play with focus on development to become a Lead Auditor performing GCP audits of Clinical Trial sites and CROs/suppliers.
As part of the auditor role, you will also act as the QA Business Partner for the Global Clinical Development area in ALK, handling suppliers, SOPs and WINS in ALK's quality management system and you will be involved in process optimizations in general.
We are looking for a new colleague to the department Global Quality Clinical & Markets, which consists of 10 colleagues in Headquarter working with GDP, GMP, GCP, GVP and Medical Devices.
Fields of responsibilities
QA Business Partner for the Global Clinical Development department.
- Perform GCP audits hereunder planning, execution, reporting, and CAPA follow up.
- Supplier Management, selection, audits and qualification of external collaborators, service providers and distributors.
- QA review and approval of SOPs, WINs and other documentation in the ALK Quality Management System.
Your preferred professional qualifications
- B.Sc. / M.Sc. in Health Science, Pharmacy or equivalent.
- 1-5 years experience with GxP, strong drive and interest in GCP.
Your personal qualifications
- Takes responsibility and works proactively, taking initiative and actively seeks tasks, influence and initiates actions on own initiative.
- Drive and willingness to develop and take part of the many activities in the department.
- Enjoy being part of a department as relation builder and team player
- Curious to get to know new areas as well as ALK, colleagues and stakeholders.
- Produce written material that is clear, fluent and easy to understand.
Languages:
- Fluent Danish and English (verbally and written).
Travelling days:
- Approximately 5 travelling days a month 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 "Regnskabsmedarbejder", og befinder sig i kategorien "Økonomi og jura".
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.
- Regnskabsmedarbejder
- Hørsholm
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