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    Computer System Validation Specialist - Munich Metropolitan Area, Deutschland - SciPro

    SciPro
    SciPro Munich Metropolitan Area, Deutschland

    vor 3 Wochen

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    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.

    These tasks wait for you:

    • 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

    That completes your profile:

    • 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

    Benefits:

    • 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

    Information about the client:

    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.