Pwc

IN_Associate_CSV_ITRA_Advisory_Bangalore

₹11–17L ~AI est. India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Associate candidates.

The Brief

“IN_Associate_CSV_ITRA_Advisory_Bangalore at Pwc. Skills: Computer System Validation, Software Testing, IT Compliance. Provide independent assessments. Provide objective assessments”

What You'll Achieve.

Enhance credibility of information; Enhance reliability of information; Build trust with stakeholders; Create distinctive outcomes

Industry & Context.

Problems you'll solve

Risk assessment; Root cause analysis

What They're Looking For.

Must Have

4-8 years Computer System Validation, 4-8 years Software Testing, 4-8 years IT Compliance, Exposure in SDLC, Exposure in STLC, Knowledge of Waterfall, Knowledge of Agile model, Knowledge of V model, Experience in manual testing, Knowledge of GAMP5 Guideline, Knowledge of GxP, Knowledge of US FDA 21 CFR Part 11, Knowledge of EU Annex 11, Knowledge of ALCOA+ principles, Knowledge of Change Control, Knowledge of Deviation Management, Knowledge of CAPA, Knowledge of Periodic Review, Experience in authoring Computer System Validation deliverables, CSV mandatory skill

Nice to Have

Preferred exposure to CSV tools, LIMS preferred skill, QMS preferred skill

What You'll Do.

Provide independent assessments

Provide objective assessments

Evaluate compliance with regulations

Assess governance processes

Assess risk management processes

Assess related controls

Build internal audit services

Optimize internal audit services

Deliver internal audit services

Setup internal audit functions

Transform internal audit functions

Provide co-sourcing services

Provide outsourcing services

Provide managed services

Use AI risk technology

Use other risk technology

Combine IA capabilities

Address risk spectrum

Protect organizational value

Navigate organizational disruption

Obtain confidence to take risks

Power organizational growth

Author Computer System Validation deliverables

Author GxP Assessment

Author Validation Plan

Author User Requirement Specifications

Author Functional Requirement Specifications

Author Functional Risk Assessment

Author Design Specifications

Author IQ/OQ/PQ protocols

Author Validation Summary Report

How You'll Work.

Team & Collaboration

Cross-functional teams; Client stakeholders

Communication Scope

Reporting

Process & Methodology

SDLC, STLC

Full Job Description

**Line of Service** Advisory **Industry/Sector** Not Applicable **Specialism** Deals **Management Level** Associate **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](https://www.pwc.in/about-us.html)_ . 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, pr

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