Partner with product owners, product managers, business stakeholders, and SMEs to elicit, analyze, validate, and document functional and non-functional needs, business rules, product requirements, and acceptance criteria.
Translate product objectives and business needs into clear, actionable user stories, acceptance criteria, supporting documentation, and technical specifications ready for Agile delivery teams.
Analyze complex business and technical issues, existing system logic, dependencies, and opportunities to improve product outcomes, operational performance, and member or stakeholder experience.
Support product teams in defining scope, sequencing work, and clarifying requirements based on user needs, business value, system dependencies, existing architecture, and enterprise technology direction.
Conduct impact analysis and assessments for proposed product changes to evaluate system dependencies, risks, effort estimates, and traceability needs that inform prioritization, backlog refinement, and delivery planning.
Requirements
Bachelor’s degree in Computer Science, Information Systems, Business Administration, or related field; or an equivalent combination of education and related work experience.
Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance
Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies
Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ
Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards
Requirements
E
Consultant - Business Consulting Risk - CHS - CNS - Risk - Digital Risk
Consultant role within the Business Consulting Risk department focusing on CHS (Health Sciences & Wellness) and Digital Risk for Consumer Products and Healthcare sectors.
Responsibilities
Perform computer system validation (CSV) across the system lifecycle
Conduct risk assessments and validation documentation
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Ensure compliance with 21 CFR Part 11 requirements for electronic records, electronic signatures, audit trails, and access controls
Maintain knowledge of GxP-regulated computerized systems
Consultant role focused on Digital Risk within Consumer Products and Health Sciences sectors, requiring computer system validation (CSV) and GxP compliance expertise.
Responsibilities
Computer system validation (CSV) across the system lifecycle
Requirements, risk assessment, testing, and validation documentation
Managing 21 CFR Part 11 requirements for electronic records and signatures
Preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Consultant in Business Consulting Risk focusing on digital risk and enterprise risk management.
Responsibilities
Proven experience in computer system validation (CSV) across the system lifecycle, including requirements, risk assessment, testing, and validation documentation.
Working knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures, including audit trails, access controls, and data integrity.
Skilled in preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices.
Familiar with GxP-regulated computerized systems and the compliance expectations of regulatory inspections and audits.
Capable of identifying gaps in system controls and recommending remediation approaches that align with regulatory and industry standards.
Consultant in Business Consulting Risk focusing on Enterprise, Technology, and Financial Services Risk within the CHS Consumer Products and Healthcare sectors.
Responsibilities
Identify and manage risk in client businesses
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols
Recommend remediation approaches for system controls
Collaborate across client departments to deliver solutions
Consultant in Business Consulting Risk focusing on Enterprise, Technology, and Financial Services Risk within the CHS Consumer Products and Healthcare sectors.
Responsibilities
Identify and manage risk in client businesses
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols
Recommend remediation approaches for system controls
Collaborate across client departments to deliver solutions
Consultant role within Business Consulting Risk focusing on Digital Risk for Consumer Products and Healthcare sectors (CHS).
Responsibilities
Technical Excellence: performing computer system validation (CSV) across the system lifecycle, including requirements, risk assessment, testing, and validation documentation.
Working knowledge of 21 CFR Part 11 requirements for electronic records and electronic signatures, including audit trails, access controls, and data integrity.
Preparing and executing validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices.
Familiarity with GxP-regulated computerized systems and the compliance expectations of regulatory inspections and audits.
Identifying gaps in system controls and recommending remediation approaches that align with regulatory and industry standards.
Senior Tech Specialist, Cloud EngineeringBrillio · Bangalore, India+1 more
Consultant - Business Consulting Risk - CHS - CNS - Risk - Digital Risk - GurgaonEY · Gurugram, India