泰州招聘

工作职责：

Responsibilities:

1.日常分析工作

Routine analytical work

- 协助QC经理建立化学实验室并维护实验室的日常运行；

Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab;

- 起草，复核或更新相关的SOP，检验方法和质量标准；

Prepare, review and updated related SOPs, test method and specifications;

- 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；

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;

- 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；

Participate the technical transfer, conduct the analytical method transferring work and complete the analytical method transferring report;

- 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；

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.;

- 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；

Clean, maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status;

- 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；

Assist in management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc.;

- 复核检验记录，必要时协助OOS调查；

Perform analytical record double-checking and assist in OOS investigations when necessary;

- 起草新员工的培训方案和确认计划并实施培训；

Prepare the new staff training plan and qualification plan for new staff and conduct the training;

- 协助SHE管理，确保试验室各项活动符合公司SHE的政策。

Assist in SHE management to keep the lab to be in conformity with company SHE policy.

2.GMP 符合性

GMP compliance

- 严格执行化学室的相关标准作业程序和规章制度；

Follow related SOPs and regulations strictly in chemical lab;

- 及时按照SOP的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性；

Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs;

- 积极参加对自检中所发现缺陷的整改。

Take part in actively in correction to the observations found in self-inspection.

3.培训和发展

Training and development

- 积极参加由内部或外部组织的系列培训活动；

Participate actively in serials training required to be held by internal and external;

- 发展各种工作技能并追求持续的改进。

Develop all kinds of skills in relation to work field and pursue continuous improvement.

任职要求：

Requirements:

1.本科或以上学历。

University or above.

2.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；精通化学分析技能，特别是HPLC，GC，UV，IR等；具备很强的分析问题和解决问题的能力。

Comprehensive knowledge of GMP, especially in lab management analytical method validation; Proficient in chemical analytical skills, such as HPLC,GC,UV,IR, etc.; Comprehensive analytical problem solving skills.

3.医药，生物或化学专业本科学历；制药或相关行业5年以上相关经验

Bachelor degree in Pharmacy, Biology or Chemistry; 5 years plus experience as analyst in Pharmaceutical or related industry.

4.英语水平中等

English at a intermediate level，CET-4

5.良好的计算机能力

Good computer skill.

6.工作态度热情

Passion for Customers.

7.具有合作精神

Works Collaboratively.

8.具备自我认知和自我调节的能力

Self-awareness and Adaptability.

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我们的愿景——开拓创新，造福病患，成为中国最值得信赖的医疗合作伙伴。

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