IN-Associate_CSV_ITRA_Advisory_Mumbai/Bangalore/Gurgaon

20 Minutes ago • 4-8 Years

Job Summary

Job Description

At PwC, this role focuses on providing independent and objective assessments of financial statements, internal controls, and other assurable information. It involves evaluating compliance with regulations, assessing governance and risk management processes, and related controls. Internal audit responsibilities include building, optimizing, and delivering end-to-end internal audit services, leveraging AI and risk technology. The role aims to help organizations protect value, navigate disruption, and power growth through effective internal audit capabilities.
Must have:
  • 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.
  • 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: Creating Shared Value (CSV).
  • Education qualification: MBA (Master of Business Administration).
Good to have:
  • Preferred exposure to CSV tools such as Valgenesis.
  • Preferred Skill sets: LIMS/QMS.
  • Optional Skills: Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Emotional Regulation, Empathy, Financial Accounting, Financial Audit, Financial Reporting, Financial Statement Analysis, Generally Accepted Accounting Principles (GAAP).
Perks:
  • Vibrant community of solvers
  • Purpose-led and values-driven work
  • Technology-powered environment that drives innovation
  • Rewards for contributions
  • Support for wellbeing
  • Inclusive benefits
  • Flexibility programmes
  • Mentorship

Job Details

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

.

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:

MBA

Education (if blank, degree and/or field of study not specified)

Degrees/Field of Study required: MBA (Master of Business Administration)

Degrees/Field of Study preferred:

Certifications (if blank, certifications not specified)

Required Skills

Creating Shared Value (CSV)

Optional Skills

Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Communication, Compliance Auditing, Corporate Governance, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Emotional Regulation, Empathy, Financial Accounting, Financial Audit, Financial Reporting, Financial Statement Analysis, Generally Accepted Accounting Principles (GAAP) {+ 19 more}

Desired Languages (If blank, desired languages not specified)

Travel Requirements

Available for Work Visa Sponsorship?

Government Clearance Required?

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About The Company

At PwC, our purpose is to build trust in society and solve important problems. We’re a network of firms in 152 countries with over 327,000 people who are committed to delivering quality in assurance, advisory and tax services. Find out more and tell us what matters to you by visiting us at www.pwc.com. PwC refers to the PwC network and/or one or more of its member firms, each of which is a separate legal entity.


Content on this page has been prepared for general information only and is not intended to be relied upon as accounting, tax or professional advice. Please reach out to your advisors for specific advice.

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