IN-Senior Associate_CSV_ITRA_Advisory_Ahmedabad
IN-Senior Associate_CSV_ITRA_Advisory_Ahmedabad
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Job Description
Line of Service
AdvisoryIndustry/Sector
Not ApplicableSpecialism
OperationsManagement Level
Senior 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.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.
*Why PWC
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 sets:
CSV
Preferred Skills sets:
LIMS/QMS
Years of Experience Required
4-8 years
Education Qualifications
(if blank degree and/or field of study not specified)
Degrees/Field of Study required: Bachelor of Engineering 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 Analytical Thinking Artificial Intelligence (AI) Platform Auditing Auditing Methodologies Business Process Improvement 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 Financial Audit 24 moreDesired Languages (If blank desired languages not specified)
Travel Requirements
Not SpecifiedAvailable for Work Visa Sponsorship
NoGovernment Clearance Required
NoJob Posting End Date
Required Experience:
Senior IC
Employment Type
Full-Time
