Katalyst CRO
Job Description
4 days ago Be among the first 25 applicants
Responsibilities
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
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.
Produce reports which summarize the results of the protocol executions and exception reports which identify defects or issues during test execution.
Review vendor documentation.
Requirement specification document review and approvals.
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 summary review.
Requirements
Excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
MES expertise is required.
Ability to work from Bothell, Washington.
Deliverables
Requirement Document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Test/Validation Summary Report
Job Details
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Engineering and Information Technology
Industries:
Civil Engineering
Location:
Bothell, Washington
#J-18808-Ljbffr
Responsibilities
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
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.
Produce reports which summarize the results of the protocol executions and exception reports which identify defects or issues during test execution.
Review vendor documentation.
Requirement specification document review and approvals.
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 summary review.
Requirements
Excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
MES expertise is required.
Ability to work from Bothell, Washington.
Deliverables
Requirement Document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Test/Validation Summary Report
Job Details
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Engineering and Information Technology
Industries:
Civil Engineering
Location:
Bothell, Washington
#J-18808-Ljbffr