Job Description Summary

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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

Education Qualification: B.Pharm

Degrees/Field of Study required: Bachelor of Engineering

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Associate_CSV_ITRA_Advisory (Hyderabad)
🏢 PwC Service Delivery Center
📍 Hyderabad