Computer System Validation Specialist

Join global organization with 82000+ employees around the world, as a Computer System Validation Specialist based in IQVIA Bangalore. You will be part of IQVIA’s world class technology team and will be involved in design, development, enhanced software programs or cloud applications or proprietary products.

Job Overview:

Under general supervision, conducts quality assurance validation and testing of Quality Management software applications.

Essential Functions:

• Understands and reviews system functional requirements.
• Responsible for performing validation of quality management computer system by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
• Create validation plans, test protocols and summary reports.
• Coordinate and executes validation change control.
• Collaborate in manual and/or automated test case planning.
• Executes test plans according to approved procedures.
• Identifies, documents, tracks, and escalates issues, as appropriate.
• Investigate defects, document defect tracking and reports test results.
• Coordinates with Product Managers and Engineering development teams in investigating and resolving issues.
• Collaborate with interdepartmental team members. Works with Developers, Tech Leads/Managers, BAs/Consultants, and other software product stakeholders throughout the SDLC.
• Attend update meetings and provide status updates of current projects.
• Provide validation artifacts to customer and track customer feedback.

Job Requirements:

• Computer Systems Validation (CSV) experience required.
• Knowledge and understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
• Working knowledge of Microsoft Office applications.
• Working Knowledge of 21 CFR Part 11 compliance in a GMP regulated industry, Data Integrity, GDP, and adherence to ALCOA principles.

Qualifications:

Bachelor's Degree Computer Science, a related field, or equivalent experience required.  Master’s degree preferred.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com