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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

• qualifications

  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

• +41 58 201 55 00
• Randstad Merck Aubonne