Pwc

IN-SeniorAssociate_CSV_ITRA_Advisory_Ahmedabad

₹15–25L ~AI est. Ahmedabad, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“IN-Senior Associate_CSV_ITRA_Advisory_Ahmedabad at Pwc. Skills: Computer System Validation, Software Testing, IT Compliance. Author Computer System Validation deliverables. Perform GxP Assessment”

What They're Looking For.

Must Have

4-8 years work experience in Computer System Validation (CSV), 4-8 years work experience in Software Testing, 4-8 years work experience in IT Compliance, Exposure in Software Development Life Cycle (SDLC), Exposure in Software Testing Life Cycle (STLC), Knowledge of SDLC methodology like Waterfall, Knowledge of SDLC methodology like Agile model, Knowledge of V model of CSV, Experience in manual testing, Experience in defect tracking and reporting, 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, Bachelor of Engineering

Nice to Have

Preferred exposure to CSV tools, MBA

What You'll Do.

Author Computer System Validation deliverables

Perform GxP Assessment

Develop Validation Plan (VP)

Develop User Requirement Specifications(URS)

Develop Functional Requirement Specifications(FRS)

Perform Functional Risk Assessment (FRA)

Develop Design Specifications (DS)

Develop IQ/OQ/PQ protocols

Develop Validation Summary Report (VSR)

Full Job Description

**Line of Service** Advisory **Industry/Sector** Not Applicable **Specialism** Operations **Management Level** Senior 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 orien

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