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QA CSV Engineer
vor 3 Monaten
Key Responsibilities
· Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended.
Your primary responsibilities will include:guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
· Contribute to risk assessments and participate to test scripts for computer system validation activities
· Supervise validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
· Document validation activities, findings, deviations and CAPA in compliance with regulatory requirements
· Conduct reviews and ensure software development adheres to industry standards and best practices
· Collaborate with cross-functional teams, including Quality Assurance, IT, and subject matter experts, to ensure successful validation efforts
Qualifikationen
Required Qualifications
· Bachelor's degree in Computer Science, Engineering, or a related technical field
· Minimum of 4-7 years of experience in computer system validation or quality assurance roles within regulated industries
· Comprehensive knowledge of CSV regulations, guidelines, and industry standards (e.g., FDA, EMA, GAMP)
· Proficiency in validation methodologies, tools, and techniques (e.g., risk assessment, test script development, defect management)
· Strong analytical, problem-solving, and documentation skills
· Excellent communication and interpersonal abilities for collaborating with cross-functional teams
· Familiarity with software development life cycles and quality assurance practices
· SAP S/4 HANA (or different version) experience needed
Preferred Qualifications
· Experience with validation of various computer systems (e.g., ERP, LIMS, MES, SDLC tools)
· Knowledge of Agile and DevOps methodologies and their impact on validation activities
· French and English
