宜昌招聘

Job Purpose (State in a nutshell the overall objective of the role)
工作目的(简单介绍该职位目标)

Implement process validation and cleaning validation, take responsibility of prepare relevant risk assessment, protocol preparation, execute validation activities per QM's requirement, lead to fulfill production dept relevant quality modules gap analysis and CAPA implementations .

Major Accountabilities (Describe the main results of the role to be achieved )
主要职责(描述该职位要取得的结果)

(1) Lead validation in Production department
a) Responsible for process validation, cleaning validation
负责生产工艺验证、清洁验证工作；
b) Participate in and support equipment qualification,
参与及支持设备确认工作；

(2) quality improvement
负责质量提升
a) Responsible for leading Quality Manual and Quality Directive implement ,
负责领导部门内实施质量手册和质量指引；
b) Responsible for leading risk assessment,
负责领导部门内实施风险分析；
c) Responsible for tracking CAPA（corrective action and preventive action） implement and close品on time,
负责部门内纠正/预防措施的实施跟踪并督促其完成
d) Responsible for tracking deviation and non-conformance，and their handling and close on time,
负责跟踪并督促部门内偏差和不符合情况处理，并督促其完成；
e) Responsible for the annual deviation and non-conformance review, and work out improvement plan,
负责部门内年度偏差和不符合情况回顾 并制订改进计划；
f) Responsible for collecting quality related data in process, analysis and work out improvement plan,
负责生产过程中各种与质量相关的数据收集、整理和分析，并制订质量改进计划；
g) Responsible for BPR defects collection, record all the observations and report in time for the further corrective action and preventive action.
负责批记录等记录缺陷的收集，及时记录和报告所有的缺陷以作进一步的纠正的预防措施，提高一次合格率；
h) Responsible for production process quality, the check of critical steps or aspects which may influence the quality of products and relevant operation monitoring, make sure all the process compliance with GMP.
负责生产过程、关键工序或可能影响产品质量方面的检查及相关工作检查等，确保所有生产过程符合GMP要求；


(3) Internal audit
内部审计
a) Responsible for performing internal audit and following up.
负责内部审计执行和跟进。
(4) Reporting and other assignments from superior,
负责上级安排的其它工作
(5) Obey and follow up corporate HSE/Quality policy, SOP and National regulation, to make sure full compliance.
遵守集团健康安全环境政策、质量方针、SOP和国家法律法规，确保合规工作。

关于诺华山德士

山德士，诺华集团非专利药业务部门，是全球非专利药行业的领导者。山德士提供约1100种国际品质、亲民价格的非专利药。山德士拥有约26000名员工，业务遍及全球约140个国家，在生物仿制药、注射剂、眼科药物和皮肤科药物领域名列全球榜首，在吸入剂领域排名全球第五。山德士的主要产品系列包括抗生素、治疗中枢神经系统紊乱、胃肠道、心血管疾病的药物和激素类药物。除了以上药品，山德士还开发、生产和销售药物活性成分、生物活性成分及抗感染药物。近年来，山德士业务强劲增长，并进行了一系列的收购，包括斯洛文尼亚的莱柯、加拿大的Sabex、德国赫素、美国Eon Labs、奥地利的依比威制药公司、美国Oriel Therapeutics和Fougera制药公司。2012年，山德士全球销售额达87亿美元。