Global GxP ALM & Automation Specialist

ALK; Hørsholm; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

ALK is seeking a GxP System Specialist to own and enhance the ALKALM-based systems and drive GxP automation in a global IT setting. You will support CSV activities, help maintain QMS documentation, and ensure alignment with regulatory expectations.

The role requires hands-on ALM experience, familiarity with OpenText UFT, and the ability to collaborate across teams located in Europe. Travel up to 10 days per year within Europe is anticipated.

Qualifications

• GxP knowledge and CSV experience are required.
• Proven experience with ALM/E2E validation and regulatory compliance.
• Strong documentation and process-following skills in validated environments.

Responsibilities

• Own and continuously improve ALK's ALM system (OpenText ALM) to stay compliant and fit for evolving regulatory needs.
• Support CSV activities for OpenText UFT within GxP scope using risk-based approaches.
• Create and maintain QMS SOPs and Work Instructions for ALM and UFT, keeping them up-to-date with regulatory expectations.
• Identify and drive improvement opportunities across Global IT systems to expand automated testing.

Skills

GxP knowledge

CSV experience

English communication

Education

Bachelor's or Master’s in CS/Engineering

Tools

OpenText ALM

OpenText UFT

Veeva Vault QualityDocs

Veeva Vault RIM

Job description

ALK is seeking a GxP System Specialist to own and enhance the ALKALM-based systems and drive GxP automation in a global IT setting. You will support CSV activities, help maintain QMS documentation, and ensure alignment with regulatory expectations.

The role requires hands-on ALM experience, familiarity with OpenText UFT, and the ability to collaborate across teams located in Europe. Travel up to 10 days per year within Europe is anticipated.