Computer System Validation (CSV) Lead

PB Consulting

Thousand Oaks, CA

Posted On: May 07, 2024

Posted On: May 07, 2024

Job Overview

Job Type

Full-time

Experience

10 - 12 Years

Salary

Depends on Experience

Work Arrangement

On-Site

Travel Requirement

0%

Required Skills

  • CCMS
  • Service Now
  • System SOP
  • OQ Protocols
  • Quality Assurance
  • OQ Scripts
Job Description
Roles & Responsibilities
  • Perform System Assessment, Data Integrity Assessment, Third-party Risk Assessments.
  • Change Record Management in CCMS and ServiceNow.
  • Work with Test Leads to ensure test coverage for all requirements.
  • Review Test Cases to ensure test cases design and Execution are performed as per Good Practices(GP) guidelines.
  • Support UAT test cases design and execution.
  • Work with System Owner(SO) to get all IQ and OQ scripts approved in ALM.
  • All Validation documents are reviewed and approved.
  • The ability to plan, organize, and execute complex validation projects within timelines and budget constraints is essential.

 

Required Skills/Qualifications
  • Minimum Years of Experience 10+ years.
  • A strong understanding of computer systems, software development, and validation methodologies is crucial.
  • Traceability, IQ and OQ protocols, System SOP.
  • Experience in ensuring the quality and compliance of computer systems in regulated industries like pharmaceuticals, medical devices, or healthcare is highly desirable.

Job ID: PC240153


Posted By

Naincy

Recruiter