Computer System Validation Analyst

Join to apply for the Computer System Validation Analyst role at Katalyst CRO

• 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

Mid‑Senior level

Contract

Information Technology

Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x