QA CSV Engineer (m/f/d).

  • Aubonne, Vaud
  • veröffentlicht am 10. Oktober 2024
  • läuft am 8. Dezember 2024 ab
bewerben

Job Details

zusammenfassung.

  • Branche
    Administration
  • Kontakt
    Caterina Del Vecchio
  • Referenznummer
    129085-40133

Beschleunige die Bewerbung, indem du dein Profil teilst

Job Details

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


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

kontaktiere uns.

wir sind da um deine Fragen zu beantworten.

CD

Caterina Del Vecchio

der Bewerbungsprozess.

Erfahre wie der Bewerbungsprozess aussieht. Finde heraus wie wir dir helfen werden, diesen Job zu bekommen.

ähnliche jobs.

alle Jobs anzeigen

  • Réceptionniste (H/F)

    • Etagnières, Vaud
    • Festanstellung
    Notre client, une concession renommée dans la vente et la location de camping-cars, recherche un(e) réceptionniste pour compléter son équipe. Passionné par le secteur du voyage et de l'aventure, ce client met un point d'honneur à offrir un service personnalisé et de qualité à chaque visiteur. Vos responsabilités :En tant que réceptionniste, vous serez l'ambassadeur(drice) de la concession, assurant un accueil chaleureux et professionnel. Vous serez amené(e
    veröffentlicht am 13. November 2024
    Notre client, une concession renommée dans la vente et la location de camping-cars, recherche un(e) réceptionniste pour compléter son équipe. Passionné par le secteur du voyage et de l'aventure, ce client met un point d'honneur à offrir un service personnalisé et de qualité à chaque visiteur. Vos responsabilités :En tant que réceptionniste, vous serez l'ambassadeur(drice) de la concession, assurant un accueil chaleureux et professionnel. Vous serez amené(e
    zeige job-details

Danke für die Anmeldung zu persönlichen Job-Benachrichtigungen.