Senior Manager CSV ITRA Advisory

As a Senior Manager in the Advisory department at PwC, your role will involve focusing on providing independent and objective assessments of financial statements, internal controls, and other assurable information. You will enhance the credibility and reliability of information for various stakeholders by evaluating compliance with regulations, including assessing governance and risk management processes and related controls. Additionally, you will play a key role in building, optimizing, and delivering end-to-end internal audit services to clients across all industries. This includes setting up and transforming IA functions, co-sourcing, outsourcing, and managed services, utilizing AI and other risk technology and delivery models. By combining IA capabilities with industry and technical expertise in areas such as cyber, forensics, and compliance, you will help organizations protect value, navigate disruption, and gain confidence to take risks for growth. Key Responsibilities: - Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance. - Exposure to Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). - Knowledge of SDLC methodologies like Waterfall, Agile model, and V model of CSV. - Experience in manual testing including Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing, and defect tracking and reporting (Preferred exposure to CSV tools such as Valgenesis). - Familiarity with GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. - Understanding of Change Control, Deviation Management, CAPA, and Periodic Review. - Proficiency in authoring Computer System Validation deliverables such as 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, and Validation Summary Report (VSR). Qualifications Required: - Minimum 10+ years of experience in CSV. - Education Qualification: B.Tech/B.Pharm/M.Sc. - Mandatory Skill sets: Quality Management Systems (QMS). - Preferred Skill sets: LIMS/QMS. - Degrees/Field of Study required: Bachelor of Engineering. At PwC, you will be part of a purpose-led and values-driven community that embraces diversity and inclusivity. We provide equal employment opportunities and have zero tolerance for discrimination or harassment based on various factors. Join us to make a tangible impact in the real world and grow personally and professionally in an innovative and supportive environment. As a Senior Manager in the Advisory department at PwC, your role will involve focusing on providing independent and objective assessments of financial statements, internal controls, and other assurable information. You will enhance the credibility and reliability of information for various stakeholders by evaluating compliance with regulations, including assessing governance and risk management processes and related controls. Additionally, you will play a key role in building, optimizing, and delivering end-to-end internal audit services to clients across all industries. This includes setting up and transforming IA functions, co-sourcing, outsourcing, and managed services, utilizing AI and other risk technology and delivery models. By combining IA capabilities with industry and technical expertise in areas such as cyber, forensics, and compliance, you will help organizations protect value, navigate disruption, and gain confidence to take risks for growth. Key Responsibilities: - Having 4-8 years of work experience in Computer System Validation (CSV), Software Testing, and IT Compliance. - Exposure to Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). - Knowledge of SDLC methodologies like Waterfall, Agile model, and V model of CSV. - Experience in manual testing including Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing, and defect tracking and reporting (Preferred exposure to CSV tools such as Valgenesis). - Familiarity with GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ principles. - Understanding of Change Control, Deviation Management, CAPA, and Periodic Review. - Proficiency in authoring Computer System Validation deliverables such as 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, and Validation Summary Report (VSR). Qualifications Required: - Minimum 10+ years of experience in CSV. - Education Qualification: B.Tech/B.Pharm/M.Sc. - Mandatory Skill sets: Quality Management Systems (QMS). - Preferred Skill sets: LIMS/QMS. - Degrees/Field of Study required: Bachelor of Engineering. At PwC, you will be part of a purpose-led and values-driven community that embraces dive