Validation Analyst Job
Job Description Job Attributes+
Waterville, ME, US
Business Consulting, Strategy and Digital Transformation
Validation Resources possess strong analytical skills and detailed understanding of the solution validation processes across regulated and non-regulated systems. They objectively evaluate information gathered from multiple sources, reconcile conflicts, breakdown high level information into details, and abstract up low-level information to a general understanding distinguishing user requests from the underlying needs of the business.
Strong understanding of any of the following : 21 CFR Part 11, 210, 211, 820(Quality System Regulations) , FDA, Risk Assessment, GAMP 5, Gap Analysis, Remediation, Retrospective Validation, Change Control, CAPA.
Experience using any of the following automated testing tools such as HP ALM, UFT, Selenium, and Mercury
CGI Life Science is seeking career driven management validation resources strong testing and analysis skills to join CGI Account Invest Team. We are experiencing rapid growth and are looking to expand our capabilities based out of our Waterville, Maine Solutions Delivery Center
This role can be housed in Waterville ME. Right now its remote until further notice.
What you’ll be doing:
• - Collaborates with clients, subject matter experts, and technical teams to execute the solutions validation deliverables for planning, development, and implementation and testing
• - Contribute to the execution and documentation for deliverables such as Validation Master Plan, CSV Regulatory Risk Assessment, Validation Protocols (IQ, OQ, PQ), URS, FRS, Requirement Traceability Matrix (RTM), and Validation Summary Report.
• - Demonstrates strong analytical skills and detailed understanding of solution validation processes including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.
• - Serves as the conduit between the customer community (internal and external customers) and the services teams in which the validation deliverables flow.
• - Exhibits knowledge of emerging industry practices when solving business problems.
• - Documents complex business processes using a combination of diagrams and explanation.
• - Identifies critical issues with ease
- Life Sciences
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