IN_Associate_CSV_ITRA_Advisory_Mumbai

This role at PwC focuses on providing independent assessments of financial statements and internal controls, ensuring compliance with regulations, and evaluating governance and risk management. Specifically, the Associate will contribute to internal audit services, including function setup, co-sourcing, and managed services, leveraging AI and risk technology. Key responsibilities involve Computer System Validation (CSV), software testing, and IT compliance, applying knowledge of SDLC, STLC, GAMP5, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. The role also includes authoring CSV deliverables like Validation Plans and IQ/OQ/PQ protocols.

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)
• CSV

Good to Have

• Preferred exposure to CSV tools such as Valgenesis
• LIMS/QMS
• 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 & Benefits

• Inclusive benefits
• Flexibility programmes
• Mentorship
• Support for wellbeing

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.

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

B.Tech

Education

Degrees/Field of Study required: Bachelor of Technology

Required Skills

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}

Travel Requirements

Not Specified

Available for Work Visa Sponsorship?

No

Government Clearance Required?

No