QA CSV Engineer (m/f/d).

  • Aubonne, Vaud
  • data di pubblicazione: 7 Agosto 2024
  • scade il 5 Ottobre 2024
candidati ora >

dettagli di lavoro

dettagli offerta.

  • categoria
    amministrazione
  • Contatto
    Caterina Del Vecchio
  • riferimento
    129085-40133

velocizza la candidatura condividendo il tuo profilo

dettagli di lavoro

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


  • qualifiche

    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

contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

CD

Caterina Del Vecchio

il processo di selezione.

Sai come funziona il nostro iter di selezione? Scopri come aiutiamo le persone a trovare il lavoro giusto.

offerte simili.

guarda tutte le offerte

  • Chef de Projet en Géothermie (d/f/h)

    • Lausanne, Vaud
    • Indeterminato
    Diplomé en Technique du Batiment et expert en géothermie, tu possèdes une expérience significative (5 ans minimum) en tant que Chef de Projet ?Tu es ouvert une nouvelle opportunité ?Nous t'offrons :de rejoindre une entreprise connue et reconnue de la Suisse Romandede participer et coordonner des projets motivants à travers La Romandied'obtenir des conditions salariales attractivesTes tâches à ce poste :superviser les projets de géothermie moyenne profondeu
    data di pubblicazione: 9 Settembre 2024
    Diplomé en Technique du Batiment et expert en géothermie, tu possèdes une expérience significative (5 ans minimum) en tant que Chef de Projet ?Tu es ouvert une nouvelle opportunité ?Nous t'offrons :de rejoindre une entreprise connue et reconnue de la Suisse Romandede participer et coordonner des projets motivants à travers La Romandied'obtenir des conditions salariales attractivesTes tâches à ce poste :superviser les projets de géothermie moyenne profondeu
    mostra i dettagli dell'offerta

Fatto! i tuoi avvisi e-mail stanno per arrivare... A partire da ora invieremo direttamente nella tua casella e-mail le ultime offerte di lavoro pubblicate in linea con i criteri di ricerca che hai impostato.