Systems Validation Specialist

Limbi vorbite

română, engleză

Adresa/ adresele jobului

București


Requirements

  • Managing and coordinating all aspects of the computer systems validation activities, document development and document reviews for computerized systems in the site (250+)
  • Developing and managing GxP system lifecycle documentation
  • Conducting System Compliance Risk Assessment
  • Utilization of a risk based approach to determine the validation requirements
  • Overseeing system change requests and associated documentation
  • Managing documentation logs and document storage
  • Management of users in computerized systems
  • Maintaining system SOPs

 

Qualifications and Skills

  • Experience in computer systems validation / Quality Assurance (GxP) regulated environments.
  • Specific experience with automated testing tools
  • Experience with validating and qualifying various IT systems.
  • Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various computerized systems validation lifecycle phases
  • Self-motivated and quick learner of business processes and technologies
  • Excellent Technical Writing and Communication skills
  • Minimum of Bachelors in Computer & Electrical Engineering, Computer Science, Chemical Engineering, Industrial Engineering, Engineering Management, MIS or related IT degrees
  • Understanding of pharmaceutical manufacturing, packaging processes, warehouse processes