Senior Associate - Computer System Validation

PriceWaterhouseCoopers Pvt Ltd ( PWC ); Bengaluru; Presencial; INR 1.000.000 - 1.500.000; Jornada completa

Descripción de la vacante

PwC is seeking a Senior validation/QA professional in India to lead Computer System Validation, software testing, and IT compliance efforts. You will work across SDLC phases, apply GxP and ALCOA+ principles, and prepare key validation deliverables.

The role emphasizes risk-based testing, regulatory alignment, and collaboration with cross-functional teams in a dynamic assurance environment. The position requires 4–8 years of hands-on CSV experience, familiarity with tools like Valgenesis, and a

Formación

• 4–8 years of experience in Computer System Validation (CSV), Software Testing and IT Compliance.
• Exposure to SDLC and STLC.
• Knowledge of SDLC methodologies (Waterfall, Agile) and V-model in CSV.
• Experience in manual testing: Positive/Negative, Regression, Smoke, Sanity, defect tracking and reporting.
• Familiarity with CSV tools (e.g., Valgenesis).
• Knowledge of GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Experience in preparing CSV deliverables (URS, FRS, VP, IQ/OQ/PQ, VSR).

Responsabilidades

• Having 4 - 8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
• Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
• Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
• Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting.
• (Preferred exposure to CSV tools such as Valgenesis )
• Knowledge of GAMP5 Guideline, GxP , US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
• Knowledge of Change Control, Deviation Management, CAPA and Periodic Review.
• Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications( URS), Functional Requirement Specifications( FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)

Conocimientos

CSV

Quality systems

Regulatory awareness

Educación

M.Sc/B.Pharm/B.Tech

Herramientas

LIMS

QMS

Descripción del empleo

Job Description & Summary

At PwC, our people in audit and assurance focus on providing independent and objective assessments of financial statements, internal controls, and other assurable information enhancing the credibility and reliability of this information with a variety of stakeholders. They evaluate compliance with regulations including assessing governance and risk management processes and related controls. Those in internal audit at PwC help build, optimise and deliver end-to-end internal audit services to clients in all industries. This includes IA function setup and transformation, co-sourcing, outsourcing and managed services, using AI and other risk technology and delivery models. IA capabilities are combined with other industry and technical expertise, in areas like cyber, forensics and compliance, to address the full spectrum of risks. This helps organisations to harness the power of IA to help the organisation protect value and navigate disruption, and obtain confidence to take risks to power growth.

Why PWC

At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us . At PwC, we believe in providing equal employment opportunities, without any discrimination on the grounds of gender, ethnic background, age, disability, marital status, sexual orientation, pregnancy, gender identity or expression, religion or other beliefs, perceived differences and status protected by law. We strive to create an environment where each one of our people can bring their true selves and contribute to their personal growth and the firm’s growth. To enable this, we have zero tolerance for any discrimination and harassment based on the above considerations.

Responsibilities

• Having 4 - 8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance.
• Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
• Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV.
• Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting.
• (Preferred exposure to CSV tools such as Valgenesis )
• Knowledge of GAMP5 Guideline, GxP , US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
• Knowledge of Change Control, Deviation Management, CAPA and Periodic Review.
• Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications( URS), Functional Requirement Specifications( FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR)

Mandatory Skill sets

CSV

Preferred Skill sets

LIMS/QMS

Years of Experience required

4-8 years

Education Qualification

M.Sc/B.Pharm/B.Tech

Optional Skills

Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, AI Fluency, AI-Human Collaboration, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Security, Data Transformation, Data Visualization, Digital Tooling, Emotional Regulation, Empathy, Financial Accounting, Financial Audit {+ 22 more} Desired Languages (If blank, desired languages not specified) Travel Requirements Not Specified Available for Work Visa Sponsorship? No Government Clearance Required? No

Experience Level

Senior Level

Job Posting End Date

June 19, 2026