LIMS System Administrator for Quality Control

4 weeks ago


Ballerup, Ballerup Kommune, Denmark Genmab Full time
About the Role

We are seeking a highly skilled LIMS System Administrator to join our Quality Control team at Genmab. As a key member of our team, you will be responsible for providing administrative and developmental support to our QC IT systems in our brand-new GMP QC Laboratory.

Key Responsibilities
  • Administer and maintain the live IT systems, ensuring compliance with regulatory requirements and cGMP regulations.
  • Own the system SOPs and WIs, and associated training packages, to ensure seamless system operation.
  • Manage user access administration, provide initial and ongoing training for users, and maintain data integrity.
  • Perform all aspects of QMS processes, including Change Control, Deviations, CAPAs, and write, review, assess, and/or approve change controls for software used in QC lab.
  • Report achievements and escalate issues to ensure timely resolution.
Requirements
  • At least 5 years of documented professional experience working according to GMP in a QC setting.
  • Thorough understanding of the detailed requirements for Software Validation and current trends.
  • Experience with qualification of analytical instruments is desirable.
About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do, and are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds, and are determined to do and be your best.
  • You are not afraid to grapple with the unknown and be innovative, and have experience working in a fast-growing, dynamic company.


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