邢台招聘

Key Accountabilities

关键职责

1. Know the GMP requirement, current validation regulation and guideline to be applied and keep updated level of knowledge.

清楚当前应用的GMP要求，验证规范和指南，并不断提高知识水平。

2. Prepare and/or review the SOPs, protocol, report, concerning qualification, validation, and calibration. Implement the qualification and validation protocol.

起草、审核与确认、验证、校验有关的标准操作程序、草案、报告。并实施验证。

3. Implement the gap analysis between GQD, and improve the current conditions.

执行全面质量指南的差距分析，并不断提高当前水平。

4. Contribution to all validation execution， including new project, annual re-qualification and re-calibration, Coordination and collaboration with global validation team.

参与公司年度再校验和再确认的活动，以及新项目的验证活动。参与全球验证团队的协调和合作。

5. Contribution to the computer system and computerized system

参与计算机系统以及计算机化系统的验证

6. Contribution to workshop inspection, make sure the operation is complaint.

参与生产现场检查和监督，确保操作符合要求

7. Any other work assigned by SQO manager related to quality operation activities.

质量部经理指定的与质量有关的其他工作。

Requirements

任职要求

- University qualification or above;

本科或以上

- Pharmaceutical and /or bioengineering background,

药学或生物工程学背景

- The experience in the sterile product manufacture for more than 2 years.

无菌产品生产的工作经验

- Validation knowledge and activities know how is necessary，the capacity to operate the instruments.

具有验证相关知识，可以操作常用的验证设备

- The capacity to write the protocol and reports

能够编写草案和报告

- The experience in foreign enterprise is recommended;

最好具有外资公司工作经历

- Computer skill: word, excel at least;

熟练使用word和excel

- English: Oral, read and writing skill is required

良好的英语能力