北京招聘

Ensure the processes to be controlled and meet the requirement of the quality assurance system by checking and inspecting the processes, including production, in process control, environment monitoring, quality control. Handling of investigation and deviation, customer complaint, reprocess, returned products and recall, according to the requirement of Roche head quarter, Chinese GMP, European GMP and the related regulation.

按罗氏总部、中国GMP、欧洲GMP和有关法规的要求对产品生产制造、制程控制、环境检测、检验过程等结果进行审核确认，处理偏差调查，返工，退货及召回程序。确保所有过程处于受控状态，符合质量保证体系的要求。

Primary responsibility:

- Collect and generally review the product releasing documentation, analyze and coordinate the deviation happened during production, implement its corrective action to ensure timely release of products within the defined lead time.

产品放行文件汇总及初审，生产过程偏差分析及协调，实施改进，确保成品在规定时间内放行。

- By implementing management of deviation and investigation in Tec. Division, ensure all of the deviations are timely corrected and the entire manufacturing and quality system is under the control.

对技术部内所产生的偏差进行协调与管理，确保所有偏差都得到及时整改，整个生产及质量体系处于受控状态。

- By reviewing the deviations periodically to analyzing and evaluating the trends.

定期回顾阶段内的偏差，分析并评估其趋势。

- Performing correctly assessment and appropriately disposition for all returned products according to returned products handling procedure, to ensure products quality.

按照退货产品处理流程对所有退货产品进行正确评估及合理处置以确保其质量。

- For a batch or batches which may lead a product deficiency or impact on the product’s quality, safety or efficacy, cooperate with other experts to initiate recall procedure to ensure all impacted products are removed from market.

对可能导致产品缺陷或者影响产品质量、安全或功效的某个产品的某批或某几批，联合其他专家小组人员启动召回程序，以确保所有受影响的产品从市场上撤回。

- Timely assessment of reprocess products according to reprocessing management, to ensure reprocessed products quality.

按照返工管理流程对需要返工的产品进行及时评估，确保返工产品的质量。

- Management of FG and FG information

产品及产品信息的管理

- Participate in LIMS system and SAP system validation to ensure the accuracy of the system data and the traceable of the validation documents.

参与LIMS系统以及SAP系统验证，确保系统数据的正确性及系统验证资料的可追溯性。

Requirements:

- University or above. Pharmacy, Chemistry, Biochemistry and equivalent

大学学历或以上学历，药学、化学、生物化学及相关学科

- At least 5 years experience in pharmaceutical or related plant

至少有5年药厂或其它相关企业工作经验。

- Good accountability of GMP understanding and implementing.

良好的GMP理解贯彻能力。

- Knowledge and experience in production and quality management.

具有生产、质量管理的知识和经验。

- Well communication skill and good accountability of problem solving.

良好的沟通,解决问题的能力。

- Language skill: Good at English, listening, speaking, reading and writing.

语言技能: 具有良好的英语听说读写能力。

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。