Aktuelle Jobs im Zusammenhang mit QA CSV Engineer - Aubonne VD, Waadt - Randstad
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Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionAs a QA CSV Engineer at Randstad, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfilling with regulatory requirements and operating as intended.Key Responsibilities:Contribute to CSV strategies, plans, and protocols in accordance with regulatory guidelines (e.g., FDA 21 CFR Part...
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Aubonne VD, Waadt, Schweiz Randstad VollzeitJob DescriptionAs a QA CSV Engineer at Randstad, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfilling regulatory requirements and operating as intended.Your primary responsibilities will include:Contributing to CSV strategies, plans, and protocols in accordance with regulatory guidelines...
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QA CSV Engineer
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Aubonne, Schweiz Randstad (Schweiz) AG VollzeitKey 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.,...
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QA Engineering Expert
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QA CSV Engineer
vor 2 Monaten
We are seeking a highly skilled QA CSV Engineer to join our team at Randstad. As a CSV Validation Expert, you will play a critical role in ensuring the compliance and integrity of our computerized systems.
Key Responsibilities- Contribute to the development of CSV strategies, plans, and protocols in accordance with regulatory guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5)
- Participate in risk assessments and test script development 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 to 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
- 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
- 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 language proficiency