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Quality Assurance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full time
About Us

Lundbeck A/S, a global pharmaceutical company, is committed to transforming lives through innovative treatments for brain disorders.

We are seeking an experienced IT QA specialist to join our Corporate IT QA Department, where you will play a critical role in ensuring the quality and compliance of our IT systems.

Job Description

This is an exceptional opportunity to further develop your professional expertise as a Quality Assurance Specialist.

You will work across Lundbeck's organization, managing a wide range of activities throughout GXP areas.

Based on your profile and experience, you may be working with major projects such as MES (PAS-X and Inmation), Veeva, or Safety Surveillance for the pharmacovigilance area.

Your responsibilities will include:

  1. Managing internal and external audit programs and performing audits on-site and remotely.
  2. Developing and maintaining risk-based computer validation methodologies.
  3. Implementing validation strategies for specific IT systems, focusing on business processes and data integrity.
  4. Supporting major projects in testing, validation, definition of strategies, and maintenance procedures.
  5. Identifying, describing, and mitigating potential data integrity risks related to GXP IT systems.

In this role, you will collaborate with skilled colleagues across the organization, contributing to the pharmaceutical value chain and making a positive impact on patients suffering from brain diseases.