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Computer System Validation Specialist
vor 2 Monaten
Job Summary
We are seeking a highly skilled Computer System Validation Specialist to join our team at SciPro, a leading CDMO specializing in aseptic filling. As a CSV Specialist, you will play a critical role in ensuring the quality and integrity of our systems and processes.
Key Responsibilities:
- Qualification and Validation: Organize and execute qualification and validation of GMP-relevant systems to ensure compliance with regulatory requirements.
- Regulatory Compliance: Maintain systems to ensure compliance with GMP regulations and data integrity standards.
- Documentation Management: Create, review, and approve relevant documentation, including qualification and validation reports.
- Change Management: Implement change processes to ensure seamless transitions and minimal disruption to operations.
- Training and Development: Provide training in the CSV and data integrity area to internal and external partners.
Requirements:
- Education: University degree in natural sciences, engineering, or IT.
- Experience: 2+ years of experience in Computer System Validation.
- Skills: Knowledge of Data Integrity requirements, familiarity with regulatory requirements and GMP standards, strong work ethic, and team spirit.
- Language: Fluency in German and English.
Benefits:
- Work-Life Balance: 37.5 hours per week (hybrid), 30 days of vacation.
- Positive Work Environment: Exciting and challenging tasks, positive working atmosphere, and teamwork.
- Professional Growth: Opportunities for personal and professional growth.
