岗位职责：

• 1、制定验证计划:负责系统从开发到上线全流程的验证工作，确保所有文档符合法规要求，版本清晰可追溯。
• 2、执行测试与验证:根据计划独立开展各类测试(包括需求验证、功能测试、集成测试、UAT验收等),并推动解决问题直到闭环。
• 3、环境搭建与维护:配合搭建和维护标准化的测试环境(包括服务器、数据库、操作系统等)，确保验证环境与生产环境一致且稳定，保障数据安全。
• 4、输出高质量报告:负责编写清晰、准确的验证总结报告，确保所有产出物都符合SOP(标准作业程序)要求。
• 5、项目支持:根据项目进度，灵活调整验证策略。配合团队完成其他相关技术任务。

任职要求：

• 1、经验背景:本科及以上学历(计算机、药学、生物工程等相关专业优先)，拥有1年以上系统测试、验证或QA相关工作经验。
• 2、行业认知(加分项):了解制药、医疗器械或生物科技行业的法规要求(如GAMP 5、FDA 21 CFR Part 11等)。有LIMS、ERP、QMS或电子批记录系统的验证经验者优先。
• 3、专业技能:了解计算机化系统验证(CSV)流程,理解验证计划、可编写测试脚本并执行测试。
• 4、语言能力:基本英语读写能力。
• 5、软性素质:做事严谨细致，具备良好的沟通能力，能业务团队顺畅协作。

Responsibilities：

• 1 质量管理体系的建立与维护
• 1.1协助标准操作规程文件的全生命周期的管理
• 1.2 协助维护标准操作规程清单
• 2 培训支持
• 2.1 协助安排与开展法规培训、新员工培训、员工年度培训等
• 2.2 监督培训合规情况
• 3 供应商评估与监督
• 3.1 协助制定供应商评估计划
• 3.2 与供应商代表及内部相关人员协调供应商评估的范围、时间及后勤安排
• 3.3 开展供应商评估工作
• 3.4 撰写供应商评估报告并按需跟进整改情况
• 4 支持公司内审活动
• 4.1协助制定内审计划
• 4.2协调与准备内审工作
• 4.3协助实施内审并完成文件记录
• 4.4协助撰写内审报告，并收集针对发现问题的整改回复
• 4.5 协助监督整改计划的完成情况
• 5 QI及CAPA管理
• 5.1评估疑似质量事件并确认其严重程度
• 5.2支持并监督CAPA完成情况
• 5.3开展有效性检查，确保定期审查管控措施的落实
• 6 支持客户审计/监管机构检查:
• 6.1 协助与客户代表协调审核/核查的范围、时间及后勤安排
• 6.2 代表公司介绍质量管理体系，主持并监督与客户代表的会议(如需
• 6.3 及时响应审核/核查过程中的需求
• 6.4 协调审核/核查回复的收集与审查
• 6.5监督回复中承诺事项的完成情况
• 7 支持计算机化系统验证
• 7.1 协助审阅计算机化系统验证过程文件的审阅

任职要求：

• 1.医药、护理、生物等相关专业，本科及以上学历
• 2.2年以上GxP QA工作经验
• 3.熟悉药物临床试验相关法规指南
• 4.具备良好的逻辑思维、系统思维、批判性思维能力
• 5.责任心强，良好的沟通能力和时间管理能力
• 6.英语熟练

Responsibilities：

• Responsible for the delivery of Medical Imaging and services to sponsors within expected timelines and budget
• Resource planning and management
• Conducts study start up and ongoing meetings (internal and external)
• Facilitates preparation of all study specific manuals
• Facilitates development and validation of applications
• Performs scheduling of activities and deliverables in conjunction with client and internal stakeholders
• Manages Independent Review process
• Performs/ facilitates project specific team training
• Contributor to business support activities such as cost estimation, quote preparation and bid defense meeting.
• Assesses Project specific financial performance and instigates required improvements.
• Ensure invoice issued in timely way when the service confirmed by sponsor and the service fee collected on schedule

Requirements：

• Bachelor's degree Degree in a technical discipline (Science, Biomedical Engineering, Computing, etc.) or a related study, or equivalent project-related experience.
• Previous Project Management experience required and preferably a life sciences background either professionally or academically. 
• Knowledge of project management concepts and approaches preferred
• Experience of regulated environments (GxP, Financial, etc…) or relevant testing experience from another domain that is transferable
• A self-starter and able to work under own initiative
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Ability to effectively delegate work to team members
• Must have the ability to work methodically in a fast-paced, time-sensitive environment
• Demonstratable ability to apply critical thinking to problems and tasks
• Proactively participates in skills improvement training and encourages their teams to participate
• Fluent English and Chinese communication skills (working experience in multinational enterprises is preferred)

We Offer：

• Competitive salary and benefits.
• Good Career development and training opportunities.
• Opportunities to work and exchange abroad.
• Relaxed and harmonious working environment.

Please send your CV and cover letter to hr@pixelwiser.com if you have interesting in this position.