Systems Validation Specialist
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- 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