计算机系统验证负责人 - 加拿大
Lead, Computerized Systems Validation - Canada
描述
CSV主管是负责在系统生命周期内领导复杂、高风险的计算机化系统验证工作的高级个人贡献者和专业领域专家。与计算机化系统验证副经理紧密合作，CSV主管提供验证策略、计划、执行和报告方面的技术专长；确保验证交付物的质量和完整性；并推动基于风险、数据完整性和GxP要求的一致应用。该角色与系统负责人、运营、IT、质量及供应商合作。该职位不承担常规的人员管理责任，但可能协调项目团队并提供职能方向。
要求
更具体地说，CSV主管需要：
- 领导新GxP计算机化系统的验证工作流、升级和系统退役，与系统负责人、业务部门、IT、质量及供应商协调活动和交付物。
- 促进项目启动和风险评估讨论，以确定GxP影响、系统关键性、验证范围、适用控制措施、供应商利用程度以及基于风险的验证策略。
- 根据适用程序制定、审查和/或批准验证交付物，包括验证计划、用户需求规范、系统风险评估、功能和配置规范、测试脚本、数据迁移验证、可追溯性矩阵、偏差记录和验证总结报告。
- 提供验证执行的技术监督，确保客观证据完整且可追溯，并在发布或关闭前及时解决测试缺陷、差异和文档缺口。
- 对验证包进行同行评审，并对确保所分配的包完整、内部一致、可追溯、可接受检查，并符合适用政策、SOP、法规和行业实践负责。
- 评估供应商验证文档，以确定供应商证据可被利用的程度，并在需要时支持供应商资质或审计活动。
- 主导或提供CSV监督，涵盖生命周期控制，包括变更控制、定期审查、访问和安全考虑、备份和恢复、数据迁移、归档、业务连续性、CAPA和系统退役。
- 在复杂验证项目中担任团队支持角色
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Description
The CSV Lead is a senior individual contributor and subject matter expert responsible for leading complex, high-risk computerized system validation initiatives across the system lifecycle. Working in close collaboration with the Associate Director, Computerized Systems Validation, the CSV Lead provides technical expertise for validation strategy, planning, execution, and reporting; ensures the quality and completeness of validation deliverables; and promotes consistent application of risk-based, data-integrity, and GxP requirements. The role partners with system owners, operations, IT, Quality, and vendors. The position does not carry routine people-management accountability but may coordinate project teams and provide functional direction.
Requirements
More specifically, the CSV Lead:
- Leads validation workstreams for new GxP computerized systems, upgrades, and system retirements, coordinating activities and deliverables with system owners, business functions, IT, Quality, and vendors.
- Facilitates project initiation and risk-assessment discussions to determine GxP impact, system criticality, validation scope, applicable controls, supplier leverage, and the risk-based validation strategy.
- Develops, reviews, and/or approves by applicable procedures, validation deliverables including validation plans, user requirements specifications, system risk assessments, functional and configuration specifications, test scripts, data migration verification, traceability matrices, deviation records, and validation summary reports.
- Provides technical oversight of validation execution, ensures objective evidence is complete and attributable, and drives the timely resolution of test defects, discrepancies, and documentation gaps before release or closure.
- Performs peer reviews of validation packages and takes accountability for ensuring assigned packages are complete, internally consistent, traceable, inspection-ready, and compliant with applicable policies, SOPs, regulations, and industry practices.
- Assesses vendor validation documentation to determine the extent to which supplier evidence may be leveraged and supports vendor qualification or audit activities when required.
- Leads or provides CSV oversight for lifecycle controls, including change control, periodic review, access and security considerations, backup and restoration, data migration, archival, business continuity, CAPA, and system retirement.
- Acts as team support for complex validation or validation strategy, data integrity, electronic records and signatures, cloud/SaaS, interfaces, emerging technology, and other computerized-system issues.
- Builds effective relationships with system owners and system administrators and provides guidance on their responsibilities for maintaining the validated state of GxP computerized systems.
- Coordinates project-level CSV schedules, dependencies, priorities, risks, and status reporting; identifies resource or timeline constraints and escalates material risks to the Manager, CSV in a timely manner.
- Mentors CSV Analysts and provide day-to-day technical direction and review feedback, shares current industry practices, and supports consistent execution across the CSV team.
- Develops and delivers CSV training for project teams (system owners, business SMEs, testers) as required by projects or process changes.
- Contribute to the creation and revision of CSV policies, SOPs, templates, tools, metrics, and process-improvement initiatives, and supports implementation of approved changes.
- Maintains current knowledge of applicable computerized-system regulations, guidance, industry standards, and evolving technologies, including cloud services, connected devices, automation, and artificial intelligence, and recommends appropriate updates to CSV practices.
- Supports internal audits, vendor audits, client audits and requests for information, and regulatory inspections by preparing evidence, responding to questions, and supporting remediation activities.
Our company
At Indero, formely Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a CSV Lead, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Work location
The successful candidate for this position is given to work remotely anywhere in Argentina.
About Indero, formely Innovaderm
Indero, formely Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formely Innovaderm continues to grow and expand in North America and Europe.
Indero, formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero, formely Innovaderm only accepts applicants who can legally work in Canada
Originally posted on Himalayas