北京招聘

Responsibilities：

1.Organize cleaning validation组织清洁验证

-By coordinating the different department such as MSAT, VL, Production, QC, QA, QV to organize the cleaning validation.

通过组织协调各个部门如MSAT、VL、生产部、QC、QA、QV来组织清洁验证。

2.Implement cleaning validation实施清洁验证

-Follow up the cleaning validation GSP of Roche global, ensure the cleaning validation gsp can be implemented in Shanghai Roche.

遵循罗氏全球的清洁验证GSP，确保清洁验证gsp在上海罗氏实施。

-By creating the cleaning validation plan and sampling plan, organizing the cleaning validation activities to ensure the implement of cleaning validation.

通过创建清洁验证计划、采样计划、组织清洁验证活动来确保清洁验证的实施。

-By reviewing the plans and reports elaborated for method validation to ensure the reliable methods are established, and the validation activities are documented.

复核方法验证计划和报告，确保建立有效的验证方法和验证结果准确记录。

-By carrying out the recovery rate from coupon materials and collecting the chemical samples for cleaning validation to ensure the accuracy of sampling.

通过执行试样的回收率测试，采集化学样品来确保采集样品的正确性。

-By interpreting and reviewing the cleaning validation data generated from every cleaning validation to ensure the correctness of cleaning validation data.

通过解释和复核清洁验证过程中产生的数据来确保清洁验证数据的正确性。

3.Manage cleaning validation document管理清洁验证文件

-By periodic reviewing the CVMP , creating and updating the relevant SOP to ensure the integrality of the cleaning validation document system.

通过定期回顾清洁验证主计划、创建和更新相关SOP来确保清洁验证文件系统的完整性。

-File the cleaning validation document.

对清洁验证文件做归档管理。

4.Maintain the cleaning validation维护清洁验证

-By verifying that the training of cleaning procedures has been performed and recorded during cleaning validation to ensure the cleaning procedures were implemented correctly by production.

通过在清洁验证过程中核实清洁程序已培训和记录来审核生产部正确地执行清洁程序。

-By facilitating the development of cleaning validation program to ensure the compliance of global guideline.

推动清洁验证实施发展，确保符合总部相关要求

-By coordinating to ensure the routine microbial monitoring

协调日常的微生物监控

Qualification：

Bachelor of Science Degree or above, Pharmacy, Chemistry, Biochemistry and equivalent

理学士及以上学位，药学、化学、生物化学及相关学科

Chinese Licensed Pharmacist

执业药师

Organize and cooperate the different department to fulfill the validation task.

通过组织协调不同的部门来完成验证工作。

Professional knowledge of quality assurance, quality control or pharmaceutical production

质量保证，质量控制或制药生产专业知识

correlative Knowledge of qualification / validation

确认/验证的相关知识

English skills

语言能力-英语

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗病毒、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与政府、医疗机构以及非政府组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

更多罗氏中国信息，请登陆罗氏官网或访问罗氏招聘公众号。