Sr. Computer Systems Validation Analyst at Katalyst HealthCares & Life Sciences

Job Description:

Latest job information from Katalyst HealthCares & Life Sciences for the position of Sr. Computer Systems Validation Analyst. If the Sr. Computer Systems Validation Analyst vacancy in Foster City matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Katalyst HealthCares & Life Sciences for the position of Sr. Computer Systems Validation Analyst below matches your qualifications.

Roles & Responsibilities:

• Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC’s and Ignition Talk
• Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
• 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
• Risk Assessments
• Installation Qualification Protocols
• 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

Katalyst HealthCares & Life Sciences

Job Info:

• Company: Katalyst HealthCares & Life Sciences
• Position: Sr. Computer Systems Validation Analyst
• Work Location: Foster City
• Country: US

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Sr. Computer Systems Validation Analyst at the office Foster City above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.