QA CSV Engineer (m/f/d)
Jobdescription
Key Responsibilities
Contributeto CSV strategies, plans, and protocols in accordance withregulatory As a QA IT CSV Engineer, you will be responsible forensuring compliance for computerized systems and computerizedsystems validation, fulfill with regulatory requirements andoperate as intended.
Your primaryresponsibilities will include : guidelines (e.g., FDA 21 CFR Part 11,EU Annex 11, GAMP 5)
- Contribute to riskassessments and participate to test scripts for computer systemvalidation activities
- Supervise validationtesting, including Installation Qualification (IQ), OperationalQualification (OQ), and Performance Qualification(PQ)
- Document validation activities, findings,deviations and CAPA in compliance with regulatoryrequirements
- Conduct reviews and ensuresoftware development adheres to industry standards and bestpractices
- Collaborate with cross-functionalteams, including Quality Assurance, IT, and subject matter experts,to ensure successful validation efforts
Functie-eisen
Required Qualifications
- Bachelor's degree in Computer Science, Engineering, or a relatedtechnical field
- Minimum of 4-7 years ofexperience in computer system validation or quality assurance roleswithin regulated industries
- Comprehensiveknowledge of CSV regulations, guidelines, and industry standards(e.g., FDA, EMA, GAMP)
- Proficiency invalidation methodologies, tools, and techniques (e.g., riskassessment, test script development, defectmanagement)
- Strong analytical, problem-solving,and documentation skills
- Excellentcommunication and interpersonal abilities for collaborating withcross-functional teams
- Familiarity withsoftware development life cycles and quality assurancepractices
- SAP S / 4 HANA (or different version)experience needed
PreferredQualifications
- Experience with validation ofvarious computer systems (e.g., ERP, LIMS, MES, SDLCtools)
- Knowledge of Agile and DevOpsmethodologies and their impact on validationactivities
- French andEnglish
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