Computer System Validation Specialist

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Ballerup

Would you like to be a part of a fast-growing Medical device company? Are you familiar with working with regulatory guidelines and corporate governance best practices? Then Ambu may be the next career move for you…

Ambu is an international and inspiring company with ambitious growth targets. We develop, produce and sell medical devices and we are experiencing massive success. To ensure continued success, we are looking for a Computer System Validation Specialist to support IT projects and ensure that our company adheres to legal standards, authority requirements and in-house policies.

In this newly established and challenging position, you will be an active contributor to the business IT team located at our Headquarters in Ballerup, Denmark and will report to the CIO.

Your responsibilities
You will be responsible for supporting IT projects with computer system validation and application teams with maintaining applications in a validated state, along with evaluating the efficiency of controls and improving them continuously.

Other responsibilities include:

  • Develop and oversee control systems to prevent or deal with violations of regulatory / legal guidelines and internal policies
  • Assess and advise on the business and IT projects and changes to identify possible compliance risks
  • Prepare and head / front internal and external audits
  • Support continuous improvement of the IT Quality Management System

Key competencies
You have proven experience as a computer validation specialist and have in-depth knowledge of the industry’s standards like GAMP and regulations like 21 CFR Part 11 and ISO 13485. Furthermore, you have an excellent understanding of reporting procedures and record keeping, along with technical experience with configuration and/or development of IT applications. It is also a benefit if you are a certified compliance professional, as well as having experience with data privacy matters (GDPR).

As a person you are methodical and diligent with good planning abilities and capable of maneuvering in a multi-sourcing environment. You have an analytical mind and can “see” the complexities of procedures and regulations. Lastly, you have excellent communication and collaboration skills and can provide internal training.

As Ambu is a global company and our corporate language is English, you must be fluent in English, both written and verbally.

Ambu – a visionary and international workplace where your efforts make a difference
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success. By joining us, you will get the opportunity to work in an international head office with an informal and cross-functional working environment.

We offer a wide range of professional, social and financial employee benefits along with exciting job challenges and career opportunities contributing to your job satisfaction.

When to apply
If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until May 19th 2021, but once we have found the right candidate, this ad will no longer be online.

You can get additional information about the job and about Ambu by contacting CIO, Agnetha Mattisson at +45 7225 2000

Your application will be treated confidentially.


Information og data

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 22.4.2021, 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.
  • Øvrige
  • Ballerup

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