Katalyst CRO
Summary
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
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 system compliance to regulatory and client requirements.
Prepare and summarize reports that document the results of protocol executions and provide exception reports identifying defects or issues during test execution.
Review vendor documentation and ensure adherence to validation requirements.
MES expertise is required.
Resource must work from the 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 and update RRA (Regulatory Risk Assessment) and obtain approvals.
Post‑execution review and post approvals in ALM.
CR Implementation approvals.
Retirement Plan review and retirement summary review.
Deliverables: Requirement document, Validation/Test Plan, Requirement Traceability Matrix, Change Requests, Impact assessment document, Test/Validation Summary Report.
Education & Experience
Experience preparing and executing test documentation for GMP computerized systems.
Strong knowledge of regulatory requirements and validation methodologies.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Pharmaceutical Manufacturing
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Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
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 system compliance to regulatory and client requirements.
Prepare and summarize reports that document the results of protocol executions and provide exception reports identifying defects or issues during test execution.
Review vendor documentation and ensure adherence to validation requirements.
MES expertise is required.
Resource must work from the 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 and update RRA (Regulatory Risk Assessment) and obtain approvals.
Post‑execution review and post approvals in ALM.
CR Implementation approvals.
Retirement Plan review and retirement summary review.
Deliverables: Requirement document, Validation/Test Plan, Requirement Traceability Matrix, Change Requests, Impact assessment document, Test/Validation Summary Report.
Education & Experience
Experience preparing and executing test documentation for GMP computerized systems.
Strong knowledge of regulatory requirements and validation methodologies.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Pharmaceutical Manufacturing
#J-18808-Ljbffr