职位详情
QA专员(验证专员)-绍兴
8000-12000元
康龙化成
绍兴
3-5年
本科
08-20
工作地址

康龙化成(绍兴)药业有限公司

职位描述

工作内容:

Job Description:


1. 收集各部门年验证项目,协助上级起草公司年验证总计划及验证年度总结;

Collecting annual validation item of each department,assisit superior to drafting annual validation plan and annual validation Summary;

2. 监督各部门验证计划执行情况;

Supervise the validation plan implementation of each departments;

3. 参与各部门验证方案和验证报告的审核, 配合其他部门进行其他验证工作;

Participate in reviewing of the validation protocol and report, coordinate
other departments with their verifications;

4. 监督检查在验证实施中的偏差及整改措施;

Supervise and check the implementation of the deviation and corrective measures in validation;

5. 参与产品工艺验证的实施,监督关键工艺参数的实用性及偏差和整改措施,追溯验证最终产品质量的符合性;

Participate in implementation of product process validation, supervise the
practicality of critical process parameters, the deviation and corrective measures,track the conformity of the final product quality;

6. 起草、修订与验证有关的报告及规程;

Draft and revise the reports and procedures related to verification;

7. 起草、审核、修订、复审职责相关的文件;

Prepare, review, revise, recheck the document related to the responsibility;

8. 起草审核本部门职责相关的报告;

Prepare and review the report related to the responsibility;

9. 完成本部门领导安排的其他工作。

Complete the work assigned by the leaders.


教育背景和任职资格:

Education Background and Qualification:


1. 具有化学、制药及相关专业本科及以上学历,优秀人员可适当放宽条件,包括工作经验;

Bachelor college or above in chemistry or pharmaceutical or related majors.
The requirements of excellent personnel can be appropriately relaxed, including work experience;

2. 有3年以上相关工作经验;

Have 3 years or above work experience;

3. 熟悉原料药相关GMP 法规;

Familiar with GMP and relevant regulations about API;

4. 具有很强的团队协作意识和沟通技巧;

Have strong sense of teamwork and communication skills;

5. 具有较强的任务执行能力。

Have strong ability of task execution.


以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕

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