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