Associate CSV ITRA Advisory

As an Associate in the Deals team at PwC, your role will involve providing independent and objective assessments of financial statements, internal controls, and other assurable information to enhance credibility and reliability for various stakeholders. You will evaluate compliance with regulations, assess governance and risk management processes, and related controls. Additionally, you will be involved in building, optimizing, and delivering end-to-end internal audit services to clients across all industries. This includes IA function setup and transformation, co-sourcing, outsourcing, and managed services, utilizing AI and other risk technology and delivery models. Your IA capabilities will be combined with industry and technical expertise in areas such as cyber, forensics, and compliance to address a full spectrum of risks. This will enable organizations to leverage IA effectively, protect value, navigate disruption, and gain confidence to take risks for growth. 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 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 Qualifications: - Years of Experience required: 4-8 years - Education Qualification: M.Pharm/M.Sc/B.Tech - Degrees/Field of Study required: Bachelor of Engineering At PwC, we prioritize providing equal employment opportunities without any discrimination based on various factors. We foster an environment where each individual can contribute authentically, supporting personal and professional growth. Our commitment to inclusivity and zero tolerance for discrimination and harassment ensures that everyone can thrive at PwC. As an Associate in the Deals team at PwC, your role will involve providing independent and objective assessments of financial statements, internal controls, and other assurable information to enhance credibility and reliability for various stakeholders. You will evaluate compliance with regulations, assess governance and risk management processes, and related controls. Additionally, you will be involved in building, optimizing, and delivering end-to-end internal audit services to clients across all industries. This includes IA function setup and transformation, co-sourcing, outsourcing, and managed services, utilizing AI and other risk technology and delivery models. Your IA capabilities will be combined with industry and technical expertise in areas such as cyber, forensics, and compliance to address a full spectrum of risks. This will enable organizations to leverage IA effectively, protect value, navigate disruption, and gain confidence to take risks for growth. 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 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 Qualifications: - Years of Experience required: 4-8 years - Education Qualification: M.Pharm/M.Sc/B.Tech - Degrees/Field of Study required: Bachelor of Engineering At PwC, we prioritize providing equal employment opportunities without any discrimination based on various factors. We foster an environ