业务分析师 – GxP 与计算机系统验证
Business Analyst – GxP & Computer System Validation
作为GxP CSV业务分析师，你的任务是确保在受监管的制药和生命科学环境中运行的系统和流程得到正确定义、验证、文档化并具备审计准备性。你将负责并协调GxP验证包，将业务和法规要求转化为清晰的验证文档，并在整个系统生命周期中确保完整的可追溯性和合规性。
你将与业务利益相关者、技术团队、质量团队和验证专家紧密合作，确保需求、风险、测试、文档和变更控制符合GxP和计算机系统验证标准。
- 负责并协调包含约20份验证文档的GxP验证包，确保其完整性、一致性和审计准备性。
- 收集、分析和记录业务和系统需求，包括用户需求规范（URS）、功能需求、流程图和需求可追溯性。
- 将验证文档分类为叙述型或状态导出型，撰写叙述型文档，并确保保存适当的支撑证据。
- 按照GAMP 5、CSV和GxP要求开发和维护验证文档。
- 支持和协调IQ/OQ/PQ验证活动，包括测试文档、证据收集、审查和可追溯性。
- 执行与已验证系统和流程相关的风险评估、差距分析、变更控制和影响评估。
- 维护验证证据、可追溯性矩阵、偏差、纠正预防措施（CAPA）文档、定期评审和其他合规记录。
- 与业务、IT、质量和验证团队的利益相关者协作，确保端到端的监管和审计准备性
- 8年以上软件/数据工程、业务分析、计算机系统验证或相关领域在受监管环境中的工作经验。
- 在制药、生命科学或其他GxP受监管环境中工作的实际经验。
- 在需求收集、URS开发、功能/业务需求、流程映射和需求可追溯性方面有丰富经验。
- 具备计算机系统验证（CSV）的实际操作经验，熟悉GAMP 5原则。
- 熟悉验证文档和生命周期活动，包括URS/FS/DS、IQ/OQ/PQ、风险评估、验证策略和测试文档。
- 有支持监管审计和管理的经验
查看英文原文
As a GxP CSV Business Analyst, your mission is to ensure that systems and processes operating within regulated pharmaceutical and life-sciences environments are properly defined, validated, documented, and audit-ready. You will own and coordinate the GxP validation package, translate business and regulatory requirements into clear validation documentation, and ensure full traceability and compliance throughout the system lifecycle.
You will work closely with business stakeholders, technical teams, quality teams, and validation experts to ensure that requirements, risks, testing, documentation, and change controls meet GxP and Computer System Validation standards.
- Own and coordinate the GxP validation package, consisting of approximately 20 validation documents, ensuring completeness, consistency, and audit readiness.
- Elicit, analyze, and document business and system requirements, including URS, functional requirements, process flows, and requirements traceability.
- Classify validation documents as narrative or state-derived, author narrative documents, and ensure appropriate supporting evidence is maintained.
- Develop and maintain validation documentation in accordance with GAMP 5, CSV, and GxP requirements.
- Support and coordinate IQ/OQ/PQ validation activities, including test documentation, evidence collection, review, and traceability.
- Perform risk assessments, gap analysis, change control, and impact assessments related to validated systems and processes.
- Maintain validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records.
- Collaborate with stakeholders across business, IT, quality, and validation teams to ensure end-to-end regulatory and audit readines
- 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a related role within regulated environments.
- Demonstrable experience working in pharmaceutical, life-sciences, or other GxP-regulated environments.
- Strong experience with requirements elicitation, URS development, functional/business requirements, process mapping, and requirements traceability.
- Hands-on experience with Computer System Validation (CSV) and strong knowledge of GAMP 5 principles.
- Strong knowledge of validation documentation and lifecycle activities, including URS/FS/DS, IQ/OQ/PQ, risk assessment, validation strategy, and test documentation.
- Experience supporting regulatory audits and maintaining audit-ready validation evidence, including change controls, deviations, CAPA, and periodic reviews.
- Excellent technical documentation and authoring skills, with experience managing controlled validation documentation and complete validation packages.
- Strong stakeholder management, communication, analytical, and organizational skills, with the ability to work effectively across business, technical, quality, and compliance teams.
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Originally posted on Himalayas