Mandatory Skill
(MES - Manufacturing Execution System experience must)
Job Description
- Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
- You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
- Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
- Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation.
- MES expertise is must
- Resource has to work from Bothell location
Roles & Responsibilities
- Requirement Specification document review and approvals
- System Implementation Plan Review
- System Implementation Summary Report Review
- Review and Pre-Approve ST/UAT Test Scripts in ALM
- Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
- Post Execution Review and Post Approvals in ALM
- CR Implementation Approvals
- Retirement Plan Review
- Retirement Summary review Deliverables: Requirement document
- Validation/Test Plan
- Requirement Traceability Matrix
- Change Requests
- Impact assessment document
- Test/Validation Summary Report
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