CSV Analyst

Overview

Join the IT team to support Computer Systems Validation (CSV) activities for spreadsheet solutions used in regulated environments, with a primary focus on Microsoft Excel spreadsheet validation.

What you'll do

• Prepare, execute, and maintain validation deliverables throughout the validation lifecycle, with a primary focus on Microsoft Excel spreadsheet validation.
• Work with Business, Quality, IT, and other cross-functional stakeholders to understand intended use and requirements.
• Assess GxP impact and risk and determine appropriate risk-based validation activities.
• Author and execute validation documentation and testing.
• Manage deviations and defects.
• Support change control activities to keep spreadsheets and applicable computerized systems in a validated state and compliant with applicable GxP and regulatory requirements.

What you'll need

• Bachelor's Degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality, or a related field, with 3+ years of relevant CSV experience.
• Strong knowledge of CSV, GxP, FDA requirements, data integrity principles, and SDLC within a regulated environment.
• Hands-on experience in Microsoft Excel spreadsheet validation, including formulas, calculations, functions, macros where applicable, data controls, protection features, and risk assessment.
• Ability to independently author and execute validation deliverables, including Validation Plans, requirements, risk assessments, Test Plans, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Experience executing validation testing, documenting objective evidence and results, and managing deviations, test exceptions, and defects through resolution.
• Experience with validation and test management tools such as HP ALM/ALM.
• Knowledge of change control and maintaining computerized systems and spreadsheets in a validated state.
• Strong technical writing, analytical, problem-solving, and communication skills, with the ability to work independently and collaborate with cross-functional stakeholders.

Nice to have

• Knowledge of MasterControl and ServiceNow.

Details

• Location: Bangalore, India.
• Work schedule: Standard (Mon-Fri).
• Environmental conditions: Office.
• Position level: Systems Analyst II.