Katalyst CRO
Computer System Validation Analyst
Katalyst CRO, Foster City, California, United States, 94420
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Responsibilities
Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
Author documents related to GxP Systems
Draft Requirements and computer systems validation documents using GAMP 5
Execute test protocols for the software validation.
Initiate and execute change management for existing qualified systems.
Develop change management record, create or revise documentation if required, and execute implementation tasks.
Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
Maintaining the project plan/schedule to meet deliverable commitments.
User and Configuration Specifications
System Impact Assessments
Operation Qualification Protocols
Performance Qualification Protocols
Traceability Matrix
Summary Reports Standard Operating Procedures
Authoring Change Controls
Authoring and executing test protocols
Managing Issue Reporting, Deviations and related CAPAs
Seniority level Mid‑Senior level
Employment type Contract
Job function Information Technology
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x
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Responsibilities
Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
Author documents related to GxP Systems
Draft Requirements and computer systems validation documents using GAMP 5
Execute test protocols for the software validation.
Initiate and execute change management for existing qualified systems.
Develop change management record, create or revise documentation if required, and execute implementation tasks.
Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
Maintaining the project plan/schedule to meet deliverable commitments.
User and Configuration Specifications
System Impact Assessments
Operation Qualification Protocols
Performance Qualification Protocols
Traceability Matrix
Summary Reports Standard Operating Procedures
Authoring Change Controls
Authoring and executing test protocols
Managing Issue Reporting, Deviations and related CAPAs
Seniority level Mid‑Senior level
Employment type Contract
Job function Information Technology
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x
#J-18808-Ljbffr