qc是什么职位(【最新职位】QC Supervisor)

qc是什么职位

行业 职位 分享 资讯 故事

QC Supervisor
职位名称 学历要求 工作经验 工作地点
本科以上 3年以上 天津

岗位职责
? 有效协调组内的工作进度及人员调配并管理其化验操作,与他们一起工作保证按时准确提供化验数据。
Harmonize analysis group member, work schedule and manage analysis procedure,ensure right data can be provide in time.
? 与相关部门人员协调沟通化验安排,保证化验安排满足各种试验及验证计划
Contact with other departments; check the work schedule to ensure it can meet all the analysis task
? 审核各种报告,包括分析化验报告,仪器校正及验证报告,分析方法的验证及移交报告
Check all the report including analysis report, instrument maintenance and validation report, method validation and transfer report
? Provide leadership and technical expertise for team members
给组员提供领导和技术方面的支持
? 依据化验数据向相关生产部门提供产品质量趋势,质量警示,提示相关采取必要措施以降低质量风险
Provide product quality trend, quality alert, and suggestive relative necessary measurement according to the test results to reduce the quality risk 
? 保证实验室仪器按照标准进行校正以及分析方法的验证。
Responsible for ensuring laboratory equipment and calibrations are complete and in compliance with specifications, and analytical method validations.
? 负管理并向每位下属化验员提供工作指导,负责QC内部相关培训,培训新员工掌握化验技巧
Responsibility of management guidance and training of the analyzer, train the new personality.
? 保持分析方法、分析仪器及计算机系统的验证状态
Ensure the validation status of the analytical method, instruments and software system.
? 负责实验室文件管理,包括质量技术文件和管理文件的分类和保存,以及标准的更新,批准发放,回收销毁,建档,满足GMP/GLP/QMS/医疗器械法规要求
Manage the lab files including sort and save controlled files and quality technical files, update standards, release approved files, reclaim destroyed files, found archives, maintain standard main file in Quarts, meet GMP/GLP/QMS/medical device policy.
? 督促QC微生物实验人员合理安排产品,环境和设施等方面的微生物检验。
Supervise QC Microbiological Laboratory Analysts to provide efficient running of raw material, final product, utilities, stability, and environment and where appropriate in-process analysis.
? 保证实验室仪器按照标准进行校正以及微生物方法的验证。
Responsible for ensuring laboratory equipment and calibrations are complete and in compliance with specifications, and microbiological method validations.
? Perform self audit and QMS gap evaluation in the areas of responsibility to maintain constant quality standards and continuously develop and implement more effective and efficient ways of improving procedures and processes.
开展自检并对所负责区域的QMS差距进行分析以保证质量标准的一致性。持续开展工作方式及方法的改进。
? Monitor the reduce test and sampling box status and ensure the effectiveness and compliance.
监控减免验和取样箱的状态,并保证有效性和符合性。
? 负责协调分析方法修订和新增的方法验证与培训。
Correspond analytical method update, add and train it.
? 负责向相关部门提供实验室文件/资料,比如TTS,CSA,法规注册要求,FSDA文件等
Offer lab files and data to related department, e.g. TTS, CSA, legal registered requirement, FSDA files etc.
?收集/提供仪器的需求计划,提供仪器利用率趋势。
To collect /provide the supplement plan of instruments, to provide the trend of utilizing of instruments.
? 负责协调和安排QC人员相应仪器使用及保养技能的培训,提供技术指导和工作支持,有效指导各组负责人及仪器使用人员正确使用仪器。
Do the instrument training for QC member, provide the technical support and guide,coach all correctly use the instruments.
? 协助QC经理进行费用及预算支出控制,PIP相关工作,与其它部门协调管理QC固定资产,保证符合公司要求。
Help QC Lab manager to control the budget, expending, PIP, Management the fixed asset in QC. 
? 理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、环境健康安全等方面的标准和公司方针,遵守公司标准操作规程。
Understand and comply with the applicable local regulations of Quality, EHS and others, THE COMPANY standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
? 其它由直线经理安排的项目和工作。
Other projects and tasks as assigned by the line manager.
任职要求
1.大学本科毕业,药学或相关专业毕业;
Graduated in pharmic or relative subjects.
2.至少3年以上相关工作经验,具有至少2年质量领域的管理经验。
At least 3 years analysis experience,at least 2 yeas experience in Management
3.了解THE COMPANY质量组织和QMS系统。
Understand THE COMPANY Quality Organization and QMS system.
4.熟悉相关THE COMPANY报告系统/衡量系统/CAP系统,了解质量审计系统。
Familiar with relative THE COMPANY report system/ assessment system/CAP system/quality audit system.
5.了解国家和地方质量政策法规(GMP,GLP,药监,药检等)。
Knowledge of state and local quality policy procedure(GMP, GLP, DII, DCI etc.)
6.熟悉公司所有相关质量标准/规程,及现行CNP和国际通用标准如USP,EP。
Familiar with company quality specification and procedure, and current CNP,international universal specification such as USP,EP.
7.熟悉*****实验室管理,通晓*****药物分析方法,分析仪器及新药标准方面的知识。
Familiar with lab management,***** medicine analysis methods,instrument and new drug specification.
8.具有质检或相关证书。
Be provided with the quality analysis certification or relative certification.
9.了解*****产品基本专业知识。
Understand the product knowledge of *****.
10.具备质量管理工具的应用知识。
Be provided with the application knowledge of management tool.
11.通晓通用分析仪器知识。Familiar with the knowledge of analytical instrument.
12.计算机及外语水平。Computer and language.
13.较好的英语水平CET-4级或6级。
Good English CET band 4 or 6.
14.电脑及业务软件的使用能力。
Good using in computer and business software.
以上职位请联系:       
Felix Zhang    18915635088   [email protected]
读者觉得文章不错,欢迎转发该文章!转发永远是一种动力!

通和猎头★  拥有稳定的团队,顾问至少拥有3年以上猎头经验。
★  强大数据库:10多年的积累,存储了大量行业优秀候选人。
★  以行业细分为特色,深耕细作。
「通和猎头」分享猎头精选文章、案例、行业趋势、职场技巧和小故事。

(长按指纹,弹出“识别二维码”后可快速关注)

qc是什么职位相关文章

为您推荐

发表评论

您的电子邮箱地址不会被公开。 必填项已用*标注