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IN_Senior Associate_CSV_ITRA_Advisory

IN_Senior Associate_CSV_ITRA_Advisory

PwC Service Delivery Center

4 - 12 years

7 - 11 Lacs

hyderabad

Posted:11 hours ago| Platform:

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Skills Required

data analysis manager internal audit assurance financial reporting data modeling business process improvement analytical risk assessment outsourcing risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Having 4 to 12 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 to 12 years

Education qualification

B.Tech/B.Pharm/M.Pharm

Education

Degrees/Field of Study required Bachelor of Engineering, Bachelor of Technology

Degrees/Field of Study preferred

Required Skills

Creating Shared Value (CSV)

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