QC Supervisor

Your Responsibilities:
Job Purpose 岗位目的:
• 负责原辅料,中间品,半成品及成品,包装材料和微生物方面的日常化验工作管理使之有效进行,确保放行的产品符合当地法规要求,并为相关部门提供化验数据支持。负责相关产品验证的化验支持。依据工厂的需求,指导,法规和市场方面的需求准备物料标准,并能持续改进改进工作流程。

Response for the efficiency of the analysis of RM,intermediates/finish goods and micro part, ensure the released product, material can meet the local requirements, support the relative department with the analysis data. Response of product and process validation. prepare specifications accurately to meet the site updated requirements, company guidelines, regulatory and market requirements and to continuously improve the process to achieve operational excellence.

• 负责原有老产品的分析方法的验证及回顾,以及新产品的技术移交工作的有效实施,并为本部门提供化验技术支持,方法改进。负责中间品、半成品及成品分析方法的更新和回顾及相关产品质量文件管理,包括分析方法变更控制,验证文件,产品质量趋势分析等,及与总部、法规部门等往来资料。
Take charge of the analytical method validation of all old products and the technological transfer of new products, support QC test in technological aspect and methodological improvement. Take charge of update and review of all analytical method related to intermediates and finish goods and management of all product quality files including change control of analytical method, validation file, product quality trend etc, and transfer files with GSK and legal department.

Key Responsibilities主要岗位职责:

• 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、葛兰素质量管理体系及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, GSK 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

Why You?

Basic qualifications:
Specialised Knowledge 专业知识:
• 文化程度(学历/专业) education background
大学本科毕业,药学或相关专业毕业;Graduated in pharmic or relative subjects.任职经验
• 任职经验Experience on Job
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
• 专业知识/技能Knowledge /Skill
 了解GSK质量组织和QMS系统Understand GSK Quality Organization and QMS system
 熟悉相关GSK报告系统/衡量系统/CAP系统,了解质量审计系统Familiar with relative GSK report system/ assessment system/CAP system/quality audit system.
 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.)
 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.
 熟悉TSKF实验室管理,通晓TSKF药物分析方法,分析仪器及新药标准方面的知识Familiar with lab management, TSKF medicine analysis methods, instrument and new drug specification.
 具有质检或相关证书Be provided with the quality analysis certification or relative certification.
 了解TSKF产品基本专业知识Understand the product knowledge of TSKF
 具备质量管理工具的应用知识Be provided with the application knowledge of management tool.
 通晓通用分析仪器知识Familiar with the knowledge of analytical instrument.

• 计算机及外语水平 Computer and language

较好的英语水平CET-4级或6级
Good English CET band 4 or 6
电脑及业务软件的使用能力
Good using in computer and business software.

• 能力要求 Other ability

良好的职业道德,诚信、认真、细致
Good professional moral , honesty, staidness, carefulness
一定的质量敏感性
Good sensitivity on Quality
较强的团队工作,培训指导能力
Powerful team work and team training
较强的分析和创新能力
Powerful analyses and innovation
较强的新技术接收能力, 具备技术指导能力
Powerful reorganization of new technology, and provide with technical guidance capability

Preferred qualifications:
N/A

Why GSK?:
N/A

Contact information:
You may apply for this position online by selecting the Apply now button.
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