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验证专员

工作地点:无锡         所属类型:QA         发布时间:2020-07-03

岗位描述:

1.参与GMP验证体系建立,按照验证总计划的要求,实施设备、公用系统等验证与再验证工作,确保所有设备、设施符合国内现行的GMP要求以及美国cGMP要求。

Participate in the establishment of the GMP validation system, and implement validation and re-validation of equipment, utility systems, etc. to ensure that all equipment and facilities meet the GMP requirements of China and cGMP requirements of the US.

2.学习国内外药品法律、法规,确保验证工作的合规性。

Learn the national and international pharmaceutical laws and regulations and ensure the compliance of validation work.

3.参与制定验证计划和验证方案,撰写验证报告及总结,并参与以下的验证活动:

设备验证(包括生产设备、实验室设备和公用系统)

工艺开发及验证

计算机控制系统验证

清洁验证

Participate in the preparation of validation plans and protocols, draft validation reports and summaries, and participate in the following validation activities:

Equipment validation(including production equipment, laboratory equipment and utility system)

Process development and validation

Computer system validation

Cleaning validation

4.验证方案批准后,与相关部门人员协调,确保验证方案顺利实施。

After the validation plan or protocol is approved, coordinate with personnel of relevant department to ensure the implementation of the validation plan.

5.参与处理验证过程中产生的偏差或变更,组织相关部门完成调查及评估。

Participate in handling deviations or changes during the validation process, and organize relevant departments to complete the investigation and evaluation.

6.负责各项验证记录、验证报告的审核管理工作。

Responsible for the review and management of validation records and reports.

7.负责验证耗材及仪器的管理。

Responsible for the management of the materials and equipment used for validation.

8.负责仪器设备的校验工作。

Responsible for calibration of equipment and instrument.

9.上级指派的其他职责。

Other duties as assigned by superior.

任职资格:

1.制剂、制药工程、药学或其他相关专业本科及以上学历。

Formulation, Pharmaceutical Engineering, Pharmacy or other relevant education background, bachelor degree or above.

2.具有三年及以上的制剂设备验证或GMP口服固体车间生产经验,接受过与口服固体制剂相关的专业知识培训,能够熟练操作维护相关设备。

More than three years of practical experience in formulation equipment validation or GMP oral solid formulation production, have received professional training related to oral solid formulations, proficiency in operating and maintaining related equipment.

3.中、英文听说读写熟练,能够起草中、英文验证文件。

Proficiency in listening, speaking, reading and writing in Chinese and English, and able to draft validation documents in Chinese and English.