The CSV QA Specialist is responsible for the review and approval of Computer System Validation (CSV) deliverables to ensure compliance with GxP, regulatory requirements, and data integrity standards. This role provides quality oversight for ERP Master Data Governance and Data Lake platforms, ensuring validation activities are executed in accordance with established SDLC and validation frameworks.

CSV QA Specialist Responsibilities:

· Perform QA review and approval of CSV lifecycle documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports

· Ensure all validation deliverables comply with GxP, 21 CFR Part 11, and internal quality standards

· Provide quality oversight for ERP Master Data Governance processes, ensuring data integrity and proper control of master data elements

· Review validation activities for Data Lake platforms and system interfaces, including data ingestion, transformation, and reporting workflows

· Partner with IT, Validation, Data Engineering, and Business teams to ensure SDLC and validation requirements are clearly defined and met

· Support deviation, CAPA, and change control review and approval related to validated systems

· Identify compliance gaps and drive continuous improvement in validation and documentation practices

Job Requirements:

· Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related discipline

· 5+ years of QA or CSV experience within pharmaceutical or life sciences environments

· Strong experience reviewing and approving CSV/SDLC deliverables for GxP systems

· Experience with Master Data Governance processes (SAP experience preferred but not required)

· Experience reviewing validation for Data Lake environments and system interfaces (Snowflake experience preferred)

· Familiarity with AI/data platforms is a plus

· Experience with electronic validation systems such as ValGenesis is a plus

· Strong knowledge of GxP, 21 CFR Part 11, data integrity, and SDLC methodologies

· Ability to work independently, provide QA oversight, and make risk-based quality decisions

QvalFocus Inc.

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CSV QA Specialist