QC IT Systems Administrator — LIMS & Validation Expert

Genmab; København; On-site; DKK 597,000 - 896,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is expanding its QC IT systems and seeks an IT System Administrator to join onsite in Ballerup. You will provide administrative and developmental support to QC IT systems, primarily Labvantage LIMS and Empower software, ensuring regulatory compliance and system validation.

You will own validation packages, SOPs and training, collaborate with QA and application managers, manage user access, and help shape the way we work with laboratory IT to support cGMP in a fast-paced, pioneering

Qualifications

• At least 5 years of professional experience working according to GMP in a QC setting.
• Strong understanding of software validation requirements and current trends.
• Experience in qualification of analytical instruments is desirable.
• Experience in leading projects and driving cross-functional initiatives/stakeholders.

Responsibilities

• Liaise between System Users, Application Managers (IT) & QA.
• Drive business aspects of system application operations, design, testing, and improvements.
• Manage user access administration and provide initial and ongoing training for users.
• Maintain validated state of GxP systems and ensure data integrity and compliance with SOPs and cGMP.

Skills

GMP experience

Software validation

Project leadership

Cross-functional collaboration

Tools

LIMS (Labvantage)

Empower

QC systems

Job description

Genmab is expanding its QC IT systems and seeks an IT System Administrator to join onsite in Ballerup. You will provide administrative and developmental support to QC IT systems, primarily Labvantage LIMS and Empower software, ensuring regulatory compliance and system validation.

You will own validation packages, SOPs and training, collaborate with QA and application managers, manage user access, and help shape the way we work with laboratory IT to support cGMP in a fast-paced, pioneering