As a Specialist (m/f/x) for CSV (Computer System Validation) and Data Integrity at this exciting pharmaceutical company, you will be responsible for overseeing and optimizing processes within the CSV area. You will contribute to an open, collegial working environment.
Your tasks will include:
* Responsible for the organization and implementation of the qualification and validation of GMP-relevant systems to ensure data integrity
* Maintenance and further development of the systems, compliance with all required compliance regulations
* Implementing regulatory requirements according to GMP Annex 11 and 21 CFR Part 11
* Collaborating globally with other sites in the DI & CSV sector
* Participating in the preparation of internal and external audits
* Supporting change management measures
* Cooperating with internal and external partners on project activities
* Actively shaping and implementing change processes
* Conducting training in the CSV and DI sectors
This completes your profile:
* A university degree in natural sciences, engineering, or IT
* 2+ years of experience in computer system validation
* Experience with data integrity requirements and principles (e.g., ALCOA+) is advantageous
* Knowledge of regulatory requirements and international GMP guidelines
* A structured and independent working style, as well as teamwork
* Fluent German and good English skills
Benefits:
* Working hours: 37.5-hour week (hybrid), 30 days of vacation + up to 10 days of compensatory time off
* Capital-forming benefits
* Good working atmosphere and teamwork across departments
* Exciting and challenging tasks with a high level of trust
* Excellent cafeteria with affordable prices and free beverages
* JobRad (company bicycle scheme)
* Opportunities for further development
About the Client:
Our client is part of a large CDMO focused on aseptic filling. The company specializes in the production of sterile pharmaceuticals and injection solutions according to high-quality and compliance standards for customers worldwide.