(Remote) Junior CSV Validation Specialist-2-3 Years-Immediate Joiners only

Company Description

SpurQLabs is an Independent Software Testing and Test Automation company that offers Testing-As-A-Service in various areas such as Manual Testing, Test Automation for Web, API, and Mobile applications, and Performance Testing. The company aims to help clients build exceptional quality products at speed while focusing on enhancing operational efficiency and consumer experience.

Role Description

This is a full-time remote role for a Junior CSV Validation Specialist with 2-3 years of experience. This role will be responsible for supporting the expansion of the client’s systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained in compliance with corporate Computer System Validation (CSV) standards.  

Minimum years of experience: 2-3 years of experience

Key Objectives/Deliverables:

Maintain Inspectional Readiness

• Ensure supported systems are validated as per the established CSV framework
• Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
• Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
• Ensure all Inspection Readiness materials are current and appropriate

Deliver Projects, Programs, and Support

• Provide consulting and interpretation on client processes as related to the supported computer system
• Provide training to customer areas on CSV-related topics as needed
• Partner with Business, Business Quality, and IT customer areas to deliver business value
• Understand customer, company, and Quality priorities
• Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
• Engage customers and QA management in appropriate discussions of risk management
• Ensure suppliers of computer systems or services meet quality expectations
• Escalate computer system quality issues to the appropriate persons
• Strive for and promote consistency within the QA Organization

Streamline and Continuously Improve

• Eliminate non-value-added activities in order to focus on activities that continuously improve assurance of quality
• Identify opportunities for streamlining and simplification, and assist in developing improved solutions
• Understand external trends and potential ramifications for the supported IT area(s)

Deliverables:

Expected to create the following but not limited to:

·      Validation Plan 

·      User Requirements/Functional Specifications/Design Configuration  

·      Risk Assessments 

·      Design Qualification / Vendor Supplied Documents  

·      Installation/Operation/Performance Qualification & Test Scripts 

·      Traceability Matrix 

·      Validation Summary Report