Introduction & Summary
On behalf of one of our clients in the pharmaceutical industry, we are seeking a skilled IT Compliance Specialist with extensive experience in quality documentation and GxP systems. This role focuses on ensuring compliance for IT components of production equipment, overseeing the full system lifecycle, and maintaining alignment with regulatory standards. Ideal candidates will possess a bachelor’s or master’s degree in science or engineering, coupled with a minimum of 3 years of relevant experience.
Main Responsibilities
The selected candidates will take on core duties that include:
Managing compliance for IT systems in automated environments.
Overseeing the entire lifecycle from system development to operation.
Establishing optimal processes in accordance with regulatory requirements (GxP).
Generating and updating compliance documentation, including ITRA's and disaster recovery plans.
Representing IT during audits and inspections.
Ensuring compliance with internal SOPs and external regulations.
Facilitating appropriate testing to validate IT requirements.
Key Requirements
Candidates must meet the following qualifications:
Bachelor’s or master’s degree in science or engineering.
A minimum of 3 years of experience with quality documentation.
Excellent oral and written communication skills in both Danish and English.
Ability to independently create technical documents.
Knowledge of IT frameworks and systems development lifecycles.
Nice to Have
Preferable skills include:
Experience in the operation and maintenance of automated systems.
Other Details
This is a full-time position located in Gentofte, focusing on compliance within the IT sector related to computerized equipment.
Location: 2820 Gentofte, Copenhagen
Allocation: 100%
Start date: 1st of July 2025
Duration: Until end of January 2026 (possibility of extension)
