Responsible for qualification of production systems and equipment, validation of manufacturing and cleaning processes, and maintaining regulatory compliance in a pharmaceutical production environment.
Responsibilities
Define qualification and validation strategies based on risk analysis
Write validation plans, protocols, reports and associated documentation
Coordinate tests, track deviations and assign qualified or validated status
Conduct periodic reviews and ensure compliance deadlines are met
Maintain procedures and contribute to process improvement
Requirements
Bachelor's or Master's in sciences, engineering or related field
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
Consultant - Business Consulting Risk - CHS - CNS - Risk - Digital Risk - Gurgaon
Consultant role focused on Digital Risk within Consumer Products and Healthcare sectors, specializing in computer system validation (CSV) and GxP compliance.
Responsibilities
Perform computer system validation (CSV) across the system lifecycle
Conduct requirements, risk assessment, testing, and validation documentation
Work with 21 CFR Part 11 requirements for electronic records and electronic signatures
Prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices
Identify gaps in system controls and recommend remediation approaches
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
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