Job i Nordsjælland
Do you have a strong quality mind-set? Do you understand the importance of a good relationship and collaboration with your stakeholders? Great! Then you might be our new QA for ENV team.
The QA Operations organization will consist of approximately 42 employees based in Kvistgaard (36) and Munich (3) and three managers. It is a growing department which currently consists of these QA teams: Drug Substance, Drug Product, EQ (Equipment Qualification), ENV (Environment), QC, RM, Warehouse, OMCL, and the QA Operations Management Team.
You will join the ENV team, together with 2 experienced QA specialists and a QA professional and become part of the QA Operations reporting to the QA Manager for the EQ and ENV Team.
You will be in our manufacturing site in Kvistgaard, Denmark
Stakeholder Management and Quality Mindset
As a QA you understand the importance of a good relationship and collaboration with your stakeholders and alignment with your Team. You are diplomatic and efficient at communicating QMS and GxP requirements to different stakeholders.
The expected activities and areas of responsibility may include:
- Review and approve SOPs, Change Control, OOSs, Deviations and Continuous Improvements in Veeva
- Support and approval of (re)Qualifications of HVAC, VHP, Clean Utility etc.
- Performance of QA Oversight and Housekeeping
- Review ...