上海招聘

Key Accountabilities:
Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab
协助QC经理建立化学实验室并维护实验室的日常运行

Prepare, review and updated related SOPs, test method and specifications
起草，复核或更新相关的SOP，检验方法和质量标准

Prepare the qualification protocol, conduct the qualification activities for equipments and complete the qualification report, such as IQ/OQ/PQ or re-qualification for chem. Lab equipment.
起草仪器的确认方案，实施仪器的确认试验并完成确认报告，例如化学实验室仪器的安装/运行/性能
确认和再确认

Participate the technical transferring ，conduct the analytical method transferring work and complete the analytical method transferring report
参与技术转移工作，实施分析方法转移并完成分析方法转移报告

Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.
起草分析方法验证/确认方案，实施相关测试，完成验证/确认报告，例如工艺验证，清洁验证，药典方法确认等

Clean， maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status.
清洁，维护试验仪器，联系供应商或合适的承包商完成仪器的确认或校验，以确保仪器设备处于良好状态

Assist in management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
协助完成化学实验室耗材管理，包括试剂，对照品，玻璃仪器，个人防护用品等

Perform analytical record double-checking and assist in OOS investigations when necessary.
复核检验记录，必要时协助OOS调查

Prepare the new staff training plan and qualification plan for new staff and conduct the training.
起草新员工的培训方案和确认计划并实施培训

Assist in SHE management to keep the lab to be in conformity with company SHE policy.
协助SHE管理，确保试验室各项活动符合公司SHE的政策

Complete other assigned tasks
完成其他指定工作

Skills and capabilities
?Comprehensive knowledge of cGMP, especially in lab management analytical method validation.
具有丰富的GMP知识，特别是实验室管理和分析方法验证方面
?Proficient in chemical analytical skills, such as HPLC,GC,UV,IR, etc.
精通化学分析技能，特别是HPLC，GC，UV，IR等
?Comprehensive analytical problem solving skills
具备很强的分析问题和解决问题的能力
?Passion for Customers
工作态度热情
?Works Collaboratively
具有合作精神
?Self-awareness and Adaptability
具备自我认知和自我调节的能力
?English at a intermediate level，CET-4
英语水平中等


Education, qualifications and experience
Essential

?Bachelor degree in Pharmacy, Biology or Chemistry.
医药，生物或化学专业本科学历

?5 years plus experience as analyst in Pharmaceutical or related industry.
制药或相关行业5年以上相关经验
Desirable
?Advanced degree, master or higher
硕士或以上学历
?International pharmaceutical quality control experience
跨国公司质量控制经历

Focus enables us to explore further and deeper.
专注使我们更长远，更深入。
 
About ISK

ISK (Isaac & Kenneth Associates) is one of the pioneers and most competitive consulting firm in North Europe,which covers the business of investment, management consulting and staffing service. With its well-established infrastructures and unique people development system, ISK works as an outstanding platform for industry-focused search organizations. Currently, ISK has already brought its executive search division to China and the following step will be management consulting and investment divisions.
ISK (Isaac & Kenneth Associates)是北欧最具影响力的咨询机构，业务覆盖投资，管理咨询以及人才服务。凭借其成熟的各项基础设施，管理机制及独特的人才发展机制，ISK 为其旗下特定行业的人才服务团队提供杰出的基础平台。ISK 已经将旗下的中高端人才服务-猎头机构引进中国，并将陆续在未来的几年里引入管理咨询和投资等事业部。

About ISK staffing service （关于 ISK－人才服务事业部）

ISK staffing service division is one of ISK's most important industry-focused search organizations. With its China headquarter in Shanghai, over 50 professionals in China, ISK staffing service division specializes in providing premium recruiting solution to our customers;
ISK 人才服务事业部是 ISK 最重要的专注于细分行业的咨询机构之一，中国总部设在上海，在全国有超过 50 人的专业招聘团队，专注于为客户提供中高端人才招聘解决方案。
Our aim is to be the most competitive search organization. We believe "competitiveness" means our capability to add tangible value to our clients.
我们的目标是成为行业中最具竞争力的猎头机构。我们相信“竞争力”意味着我们能为客户切实带来的增值能力。

www.isaac-kenneth.com