潍坊招聘

Basic Purpose of the Position
岗位的基本目标
1.To meet requirements of GMP, corporate guidelines, policies, procedures and industry standard, effectively and efficiently implement qualification and validation-related activities.
在符合GMP，总部的方针、政策，程序以及工业标准的要求下，高效执行确认及验证相关工作。
2.To ensure the uniformity of BISPL of units of measurement and the accuracy and reliability of the values of quantities, in compliance with the request of “Metrology Law of P.R. China” and cGMP, draw up the calibration schedule and carry out calibrations according to this plan.
为了保证勃林格工厂内计量单位的统一和量值的准确可靠，在符合计量法以及cGMP的要求下，制定计量器具检定、校准计划并按期完成。

Accountabilities
职责
1.Be responsible for preparing new equipment / system RA, IQ/OQ protocol and performing new equipment/system IQ/OQ activities, IQ/ OQ report and related validation summary report.
负责起草设备/系统的风险分析，安装/运行确认方案并指导执行相关测试及完成安装/运行确认报告和相关的验证总结报告。
2.Be responsible for creating requalification protocols and performing reports of requalification and periodical review.
负责起草再确认方案，完成再确认报告及周期回顾报告。
3.Ensure requalification and periodical reviews of equipments are executed within the specified time frame.
确保所有设备的周期回顾工作及再确认工作在指定的时间框架内进行。
4.Support plant CSV activities.
协助工厂计算机验证工作。
5.Implement effectively internal calibration activities for BISPL according to calibration plan.
按校准计划完成勃林格工厂的内部校准工作。
6.Coordinate and arrange the third party for verification and calibration.
负责协调、安排第三方进行检定或校准工作。
7.Update the information of the measuring instruments and verifications/calibrations; ensure that the datum of the Instruments Master List is integrated and accurate.
更新计量器具及检定、校准信息，确保计量器具台帐数据完整、准确。

Required Experience
所需的工作经验背景
1.Bachelor’s degree of a related pharmaceutical or engineering field above. Pharmacy or Engineering Technique
制药或工程领域本科学历或以上。 药学或工程技术
2.Minimum of 3 years experience of pharmaceutical industry engineering and equipment qualification.
3年以上制药工程或设备确认管理经验。
3.Good communication and inter-personal skills
优秀的沟通与人际技能

Acutalent HR Consulting Co., Ltd. is an executive search firm focusing on searching for middle to senior management positions for our European, American, and Japanese multinational company clients. Meanwhile, we provide career development plans to mid and above level customers in Acutalent’s talent pool.

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Core Competency:
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