IT Compliance & CSV Specialist (m/f/x) | Niedersachsen | Limited contract
As a competent contact (m/f/x) for all computer system validation and IT compliance issues, you can be an asset to a global, leading pharmaceutical company. You will be responsible for processing and implementation of guidelines, standards, and methods in accordance with international IT regulations.
These tasks are waiting for you:
* Engaging in exciting projects and collaborating with specialist departments to execute digitization projects while ensuring compliance with relevant regulatory requirements and computer system validation (CSV)
* Conducting qualification and validation of IT systems
* Defining, processing, and monitoring change and deviation management
* Coordinating and managing topics related to GDPR
* Providing support in both local and cross-location projects
* Delivering internal training sessions
* Preparing for authority inspections and audits
This completes your profile:
* Degree in IT, Business Information Systems, Computer Sciences or comparable qualifications with relevant work experience
* 2+ years of professional experience in an IT compliance or CSV role, preferably in the pharmaceutical industry or medical device industry
* In-depth knowledge of regulatory requirements (especially GxP, CFR 21 Part 11/EU GMP Annex 11)
* Excellent communication skills and a methodical, quality-focused approach to work
* Fluency in both German and English
Information about our client:
Our client is a global biopharmaceutical company specializing in plasma-derived therapies for rare diseases. They are dedicated to developing, producing, and distributing products to enhance patient care worldwide. With plans to expand their advanced manufacturing facilities and invest further in R&D, they offer an exciting opportunity to contribute to their mission.