Volga Partners
GMP Compliance & Validation Subject Matter Expert -AI Model Evaluation
US · United States · Remote · Freelance · Senior
Salary not stated
AI summary
About the company
Volga Partners,连接制药行业专业人士与AI模型开发评估机会的机构,聚焦制药领域AI技术发展。
Role overview
本岗位为远程项目制自由职业,隶属于Volga Partners,需评估AI生成的制药相关内容的合规性与准确性,运用制药GMP合规、验证等专业知识优化AI模型,无需AI经验,适合有制药行业经验的专业人士。
Responsibilities
- 评估AI生成制药内容的准确性、合规性与完整性
- 审查制药相关科学与监管信息
- 分析AI生成结论的技术推理合理性
- 识别AI内容中的错误与不一致
- 参考FDA、GMP、ICH等标准验证信息
- 提供专业反馈以改进AI模型性能
- 使用指定平台完成独立评估并遵守项目时限
Requirements
- 4年以上制药相关领域专业经验
- 制药相关专业本科及以上学历
- 有监管制药环境下验证与资质活动经验
- 熟悉FDA、GMP及ICH相关法规
- 掌握数据完整性、21 CFR Part 11等要求
- 具备审查验证文档与合规记录经验
- 优秀的书面英语沟通能力
- 适应任务制自由职业模式
Nice to have
- 拥有PharmD、PhD等高级专业资质
- 有主导工艺验证或清洁验证项目经验
- 熟悉IQ/OQ/PQ协议开发与执行
- 有支持FDA、EMA等监管检查经验
- 掌握Annex 11、GAMP 5等要求
Pay & benefits
- 按项目计费,时薪20-50美元
- 可远程参与项目工作
- 灵活的项目参与时间安排
- 可参与制药AI技术创新项目
Hiring process & how to apply
- 候选人需完成筛选问题与评估练习
- 通过筛选者可获得项目机会
- 具体任务与时间安排将在确认后通知
Notes for China-based candidates
- 可远程工作,需具备美国制药行业经验
- 时薪以美元结算,按项目计费
- 需具备优秀书面英语能力
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Excerpt
Remote | United States | Project-Based Independent Contractor Compensation: $20-$50 USD/hour, based on specialty, experience, and project requirements Help Shape the Future of AI in Pharmaceutical What if your expertise in Pharmaceutical GMP compliance, validation programs, qualification…
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