- Responsible for the organization and execution of the (re-)qualification and (re-)validation of GMP-relevant systems to ensure data integrity
- Maintenance and further development of systems, ensuring compliance with all required regulations
- Creation, management, review, and approval of relevant documentation if necessary
- Ensuring compliance with legal GMP regulations and internal guidelines in the areas of qualification, validation, computer validation, and data integrity
- Development and maintenance of necessary documentation templates
- Cooperation with internal and external partners in project activities
- Active participation and implementation of change processes
- Conducting training in the CSV and DI area
- A university degree in natural sciences, engineering, or IT
- 2+ years of experience in the field of Computer System Validation
- Experience with Data Integrity requirements and principles (e.g., ALCOA+) is advantageous
- Knowledge of regulatory requirements and international GMP standards
- Structured and independent working style, as well as teamspirit
- Well-versed in MS Office
- Fluent in German and good knowledge of English
- Working hours: 37.5 hours per week (hybrid), 30 days of vacation
- Good working atmosphere and teamwork across departmental boundaries
- Exciting and challenging tasks with a high level of trust
- Very good canteen with affordable prices and free beverages
- JobRad
- Opportunities for personal and professional development
Computer System Validation Specialist - Munich Metropolitan Area, Deutschland - SciPro
Beschreibung
Computer System Validation Specialist (m/f/x) | Pharmaceuticals | Greater Munich Area
As a CSV Specialist (m/f/x) for this exciting pharmaceutical company, you will be responsible for the management and optimization of processes within the CSV area. You will integrate into an open, collegial working environment.
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Our client is part of a large CDMO with a focus on aseptic filling. The company concentrates on the production of sterile pharmaceuticals and injection solutions according to high quality and compliance standards for global customers.