Quality Lead Auditor with GLP/GCLP knowledge
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Ballerup
Do you want to impact our future auditing set-up as part of a highly experienced team?
The R&D pipeline of LEO Pharma has advanced. In Global Quality Audits we are building the auditing set-up for the future and we are expanding as well. That is why we need you and your solid experience within GLP/GCLP.
If you are looking for an opportunity to influence the quality level as well as the auditing set up in an ambitious and global company, this is the right job for you. You will be part of a very experienced team of competent colleagues that share your dedication for delivering best in class quality in a business-related context. You must be motivated for expanding your field of expertise as well as supporting colleagues by sharing your experience.
Plan, conduct and report audits across pre-clinical development activities, specialized laboratories and clinical laboratories
As our GLP/GCLP Quality Lead Auditor your primary focus will be audit assurance of pre-clinical activities and clinical laboratories, meaning you must bring solid knowledge of laboratory practice and equipment – not necessarily as an auditor as we can teach you this part. Your primary tasks will be to:
- Plan, conduct and report audits of pre-clinical development activities as well as special laboratories and central laboratories used in clinical trials
- Perform audit of non-clinical studies, facilities, and suppliers
- Perform audits of central and special laboratories used in clinical trials
- Manage qualification of new vendors within GLP services and/or clinical laboratories
- Follow up on CAPA handling and completion
- Support and maintain the audit risk assessment and audit program
- Plan and conduct GLP training of colleagues
- Coordinate audit activities between the current GCP/GLP auditors
- Represent Global Quality Audits in different stakeholder fora or during inspections
- Knowledge within validation of IT systems will be a surplus
You will naturally be an important contributor or driver of improvement activities within the GLP/GCP audit team as well as across the different audit teams (GMP/GDP, PV/Affiliate, and IT GXP). You may be involved in due diligence during acquisitions. You can look forward to approx. 40 travel days annually (when COVID-19 restrictions are lifted).
Several years of experience within GLP/GCLP – not necessarily as Auditor
As Auditor you must have a genuine quality mindset and a structured work approach including the ability to keep track of multiple parallel assignments. As Auditor you must additionally be capable of handling assignments on your own as well as part of specialist teams. As part of a truly international setup you must thrive on working together with people from different cultures and get your messages across in an easily understandable English. Our global environment requires an open-minded and pragmatic attitude, including the ability to understand that there may be more than one compliant solution. Additionally, your CV comprises:
- Several years of experience within GLP/GCLP, either as Auditor or from involvement in pre-clinical development or clinical laboratory activities
- Experience with quality and/or auditing
- Willingness to expand areas of expertise to other GxP areas
- Knowledge of or motivation for building solid knowledge within laboratory IT systems
- Motivation for learning to work with the Veeva system
Global Quality Audits – your new team
You will join 17 enthusiastic and very experienced and certified Quality Lead Auditors, one Business Analysts, and one QMS project QA located at offices in Ballerup, Denmark and Segrate, Italy. Together we are responsible for conducting audits within all GxP domains globally at LEO Pharma entities as well as its suppliers. Quality in a business-related context is part of our common DNA. As such, we strive to challenge and drive the Quality path forward to ensure the success of LEO Pharma.
Contact and application
Please apply at our website. The deadline is 22 June 2021. Please note that we review applications on an on-going basis and aim to close the process as soon as we find the right match – Hence, the sooner you apply the better are your chances.
If you have any questions, you are very welcome to contact Eva Lysdal Maare, Senior Manager, Global Quality Audits at +45 3176 7467.
We look forward to receiving your application.
Information og data
Denne ledige stilling har jobtypen "Regnskabsmedarbejder", og befinder sig i kategorien "Økonomi og jura".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 25.5.2021, 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.
- Regnskabsmedarbejder
- Ballerup
- Tirsdag den 22. juni 2021
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