南京招聘

? Thoroughly implement law, regulations regarding drug quality management, organize and standardize quality management of drug manufacturing. Establish and improve quality man-agement system of drug manufacturing in company and monitor this system to ensure its efficiency. Insure only good quality product can be sale in the market. 贯彻执行药品质量管理的法律、法规，组织和规范企业药品生产质量管理工作。组织建立和完善本企业药品生产的质量管理体系，并对该体系进行监控，确保其有效运作。确保只有合格的产品销往市场。
? Responsible for below quality management activities and decision making对下列质量管理活动负责，行使决定权
approval for releasing each batch material and finished product每批物料及成品放行的批准
approval for documents of quality management质量管理文件的批准
approval for process validation and key process parameter工艺验证和关键工艺参数的批准
approval for internal specification of material and finished product物料及成品内控质量标准的批准
approval for handling of Non-conformed product不合格品处理的批准
approval for product recall产品召回的批准
Have veto to below functions may have crucial effect on product quality参与对产品质量有关键影响的下列活动，行使否决权
selection of key material suppliers关键物料供应商的选取
selection of key equipment and facility关键生产设备的选取
selection of key position such as production, quality, supply chain, engineer department生产、质量、物料、设备和工程等部门的关键岗位人员的选用
? Responsible for the training of all staff in the Quality department not only concerned with specific tasks, but with GMP as well. Responsible for the personal qualifications of the Quality department. Prohibit anybody who is not qualified to work in the Quality department. Responsible to supply adequate personnel and related facilities to engage the quality work assigned to them. 负责质量人员的专业培训和GMP培训。对从事药品质量管理和检验的人员的资历进行审核。制定质量管理和检验人员的工作职责。
? Responsible for the internal quality audit of the company, give audits report and record the process. Responsible for the management of suppliers quality audit issue, define audit plan, protocol, review of records. 负责对质量部内部进行质量审计，提出质量审计的处理意见并做记录归档。审核成品发放前的批生产记录。负责供应商的质量审计工作，确定质量审计计划，方案，审核审计报告。
? Responsible to make decision for the unqualified raw materials, packaging materials, interme-diate, bulk and finished products and checks the process of handling. Responsible for investi-gation and handling of customer complain. Responsible to review and approve change pro-posal and approval. 对不合格的原辅材料、包装材料、半成品及成品提出处理意见并监督实施。负责协助用户访问工作及处理用户投诉意见。负责审核和批准更改申请和批准报告。
? During the period of manufacturing and quality management, QA/QC manager should actively communicate and coordinate with SFDA and GQA. QA/QC manager should assist and accompany inspection team to carry out inspection work during enterprise are receiving GMP authentication or GMP on-the-spot tracking inspection. Authorized person supervises and urges company to prepare correct action of defect report to SFDA and GQA within defined timeline. Responsible for reporting implementation situation of GMP and annual quality review to SFDA and GQA based on requirement. 在公司接受药品GMP认证或药品GMP跟踪检查的现场检查期间，授权人应作为公司的陪同人员，协助检查组开展检查；并按要求督促有关部门将缺陷项目的整改情况上报药品监督管理部门和集团质量部. 负责向药品监督管理部门和集团质量部上报公司的药品GMP实施情况和产品的年度质量回顾分析情况。
? Be accountable for SOP, GMP, QM ,CHSE compliance and China laws and regula-tion.
必须有责任地符合SOP, GMP, 质量手册,集团安全健康环境和中国法律法规的要求.

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。