Über diese IN_Senior Manager_CSV_ITRA_Advisory_Mumbai Stelle bei PwC
Line of Service
AdvisoryIndustry/Sector
Not ApplicableSpecialism
RiskManagement Level
Senior ManagerJob 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.
Job Description & Summary:A Career with in............................
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
10+ years
Education Qualification
B.Pharm/M.Pharm/B.Tech
Education (if blank, degree and/or field of study not specified)
Degrees/Field of Study required:Degrees/Field of Study preferred: Bachelor of EngineeringCertifications (if blank, certifications not specified)
Required Skills
CSV (Inactive)Optional Skills
Accepting Feedback, Accepting Feedback, Accounting and Financial Reporting Standards, Active Listening, Analytical Thinking, Artificial Intelligence (AI) Platform, Auditing, Auditing Methodologies, Business Process Improvement, Coaching and Feedback, Communication, Compliance Auditing, Corporate Governance, Creativity, Data Analysis and Interpretation, Data Ingestion, Data Modeling, Data Quality, Data Security, Data Transformation, Data Visualization, Embracing Change, Emotional Regulation, Empathy, Financial Accounting {+ 32 more}Desired Languages (If blank, desired languages not specified)
Travel Requirements
Not SpecifiedAvailable for Work Visa Sponsorship?
NoGovernment Clearance Required?
NoJob Posting End Date
August 6, 2026