Pwc
IN_Associate_CSV_ITRA_Advisory_Bangalore
Neural analysis suggests this role is
optimal for Associate candidates.
“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.
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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