Quality Assurance Software Engineer - VAF128

Groupe ProductLife
Strasbourg
EUR 60 000 - 80 000
Description du poste

Quality Assurance Software Engineer - VAF128

Location: Hybrid

Industry: Biopharmaceutical Drug Development services

Contract Type: Permanent

As part of our growth, we are looking for a Quality Assurance Software Engineer specializing in the life sciences field. You will be responsible for ensuring the compliance and quality of developed software by integrating rigorous processes within agile and xOps environments.

Responsibilities

  • Ensure quality compliant software development by integrating quality into agile and xOps workflows.
  • Develop and maintain quality management systems, oversee risk assessments, and validate software using IQ/OQ/PQ strategies. Lead automating testing and compliance checks, maintaining traceability across the software lifecycle, and authoring critical validation documents.
  • Act as a liaison during audits and inspections.

Due to strong connection with the team and complexity of the position, physical presence is mandatory.

Profile

  • Master or Engineer Degree in Software Engineering with specialization or experience in Software Quality.
  • 1 to 5 years of experience.
  • French and English (both written and spoken).
  • Technical skills:
  • Development Expertise:
    • Strong knowledge and understanding of software development using Python and JavaScript frameworks.
  • Automation and CI/CD:
    • Proficient in building and maintaining automation pipelines, including unit testing and CI/CD workflows (e.g., GitLab, GitLab Runner).
  • Cloud-Native Development:
    • Familiar with developing cloud-native applications in AWS environments, leveraging services like Lambda, DynamoDB, and API Gateway.
  • Life Science SDLC and Validation:
    • Proficient in the software development lifecycle (SDLC) methodologies specific to life sciences, including defining and managing requirements (User, Functional, Design).
    • Skilled in risk analysis techniques (e.g., FMEA, HAZOP) and validation processes (Validation Plans, IQ/OQ/PQ).
  • Regulatory Compliance:
    • Familiar with software engineering regulations for life sciences, including GAMP5 and GxP compliance standards.
  • Have already performed full process of software compliance.
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