1.依据公司内部SOP，以及相关法规、指南或行业标准，见证供应商的验证/确认的执行。Witness the implementation of supplier verification/validation in accordance with the company's internal SOP and relevant regulations, guidelines or industry standards.
2.负责起草验证/确认方案和报告，包括空调系统、软化水系统、热水系统、纯化水系统、注射用水系统、压缩空气系统、氮气系统、生产设备、库房温湿度分布。Responsible for drafting validation/qualification protocol and reports, Including air conditioning system, softened water system, hot water system, purified water system, water for injection system, compressed air system, nitrogen system, production equipment, warehouse temperature and humidity distribution.
3.负责审核所有验证的相关数据，并进行趋势分析。Responsible for reviewing all relevant validation/qualification data and trend analysis.
4.识别验证/确认测试中的偏差，并提供解决偏差的建议。Identify deviations from validation/qualification tests and provide recommendations for resolving deviations.
5.负责验证/确认所用测试仪器/设备的SOP的编写和执行。Responsible for the preparation and implementation of Sops for validation/qualification of the test instruments/equipment used.
6.负责验证/确认所用测试仪器/设备的维护保养工作。Responsible for validation/qualification the maintenance of the test instruments/equipment used.
7.完成其他相关工作。Execute other related tasks.
职位要求：
1.药学、制药工程等相关专业本科及以上。Bachelor degree or above in pharmacy, pharmaceutical engineering and other related majors.
2.三年以上制药或相关行业验证工作经验。More than 3 years’ experience in validation in pharmaceutical or related industries.
3.有口服固体制剂或无菌制剂医药行业验证工作经验为佳。Experience in the validation of oral solid or sterile preparations in the pharmaceutical industry.
4.应熟悉空调系统、纯化水系统、注射用水系统、压缩空气系统、氮气系统、生产设备、计算机化系统等其中的2种以上的系统。Be familiar with more than two systems of air conditioning system, purified water system, water for injection system, compressed air system, nitrogen system, production equipment, computerized system, etc.
5.具备对问题的分析、判断及解决能力。Have ability of problem analysis, judgment and resolution.
6.具备良好的沟通交流能力。Have good communication ability.
7.熟练使用Office、CAD等办公软件。Skilled in Office, CAD, and other office software.
