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AdvisoryIndustry/Sector
Not ApplicableSpecialism
RiskManagement Level
AssociateJob 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.Why PWC
At PwC you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes forour 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 foreach 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 firms 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 Skills:
CSV
Preferred Skills:
LIMS/QMS
Years of Experience:
4-8 years
Education qualification:
(if blank degree and/or field of study not specified)
Degrees/Field of Study required: Bachelor of Technology Master of Business AdministrationDegrees/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 moreDesired Languages (If blank desired languages not specified)
Travel Requirements
Available for Work Visa Sponsorship
Government Clearance Required
Job Posting End Date
Required Experience:
IC
Full-Time