QA CSV Engineer

vor 2 Monaten

Aubonne, Schweiz Randstad Vollzeit
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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