面议
苏州工业园区 | 2年以上经验
发布时间：2021-10-21 00:05:46 |
截止时间：2021-11-26
基本信息：
- 质量管理/测试经理(QA/QC经理）
- 有经验要求
- 全职
- 3
职位描述及要求：
- MINIMUM REQUIREMENTS
Education / Experience
1. College or university degree.
2. Minimum 2 years’ experience in a testing laboratory environment, Master degrees can be exempted from the requirement.
Special Knowledge
1. GMP philosophy.
2. Equipment 3Q activities background.
3. Analytical method validation background.
Skill
1. Strong interpersonal skills.
2. Good at planning and execution.
3. Good at document management.
4. Good command of oral and written English.
5. Computer literate, knowledge of word processing and spreadsheet softwares.
岗位要求
教育/经历
1. 大专或本科以上学历。
2. 拥有至少两年以上分析实验室工作经验，研究生学历可以豁免。
特殊知识
1. 熟悉GMP 要求。
2. 熟悉实验室仪器3Q 认证要求。
3. 熟悉分析方法验证要求。
技能
1. 较好的与人沟通的技巧。
2. 擅长制定工作计划和较好执行力。
3. 较好的文件管理能力。
4. 较流利的英语（包括口语和书写）。
5. 能熟练地应用微软办公室软件。
Strictly follow procedure and responsible for the exercising of maximum care, good judgment and behaviors in preventing SHE incidents.
Co-ordinate with other shift teams to ensure that scheduled testing and release activities are completed in a timely manner with minimal delays. Perform shift and weekend duties if necessary.
Strictly follow approved test procedure with current authorized forms and ensure accuracy and integrity in raw data, calculations and results.
Investigate and document suspect or out-of-specification data regarding any analytical testing conducted in the laboratory.
Qualify, operate, calibrate and maintain laboratory facilities and instrument as schedule and procedure requirement.
Assist in maintaining adequate levels of reference standards, control samples, reagents, spare parts and GMP consumable, meanwhile, properly store them as requirement.
Assist in the training of new Analysts so as to enable them to carry out their duties in accordance with GMP.
Be accountable for method transfer/validation, and assist in the development and review of laboratory test methods.
Be knowledgeable with applicable policies, procedures and guidelines. To ensure continuous compliance to GMP and Wyeth quality system requirement in designated areas.
Execute all duties faithfully and responsibly in accordance to written procedures and to action report all observations of GMP non-conformances.
Perform or assist in additional job-related functions as directed by the supervisor.
严格遵循操作规程并遵守良好实验室行为规范，避免安全健康环境事故的发生。
和其他小组密切配合，严格按照计划完成检验并及时发送分析报告，最大程度地降低延迟发送分析报告的情况的发生。必要时，需要翻班或周末加班。
严格遵循检验操作规程和使用经批准的工作单，确保分析结果的正确性和完整性。
调查和记录发生在实验室的可疑结果或不符合质量标准的结果。
按照时间表和规程要求，完成实验室公用设施和设备的确认、操作、校验和维护工作。
保证对照品、内控对照品、化学试剂、零部件和GMP 耗品的充足库存，并按照要求保存。
协助新入职分析师完成培训，使之能够履行他们的GMP职责。
负责实验室分析方法转移或验证，协助开发和审核检验方法。
掌握相关政策、规程、指导原则，确保持续符合职责范围内的GMP要求和惠氏质量体系要求。
切实并负责地执行各项规程规定以及针对不符合项而做出的纠正措施。
完成主管交办的与工作相关的任务。
岗位条件：
- 本科
- 英语 熟练
- 不限
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