太原招聘

This section contains a list of twelve primary responsible roles. The incumbent will perform other duties assigned. 该部分包含了10个主要的责任角色，任职者还须承担一些其它指定的工作。
1. Make sure all applicable regulation related to pharmacy and medical device are identified adequately as well as lead local gap assessment process and ensure the compliance implementation in the plant. 确保充分识别适用的医药/医疗器械相关的法规，并引导完成本地化的差距分析过程和确保在工厂内合规的实施。
2. Make sure global QMS documents implementation in plant in a timely and compliance manner.
确保总部质量管理体系文件在工厂内及时有效的实施。
3. Responsible to maintain manufacturing license and certificates for both drug products and medical devices.
负责维护药品和医疗器械产品的生产许可证及认证证书。
4. Build up and maintain good relationship with relevant authorities and notified bodies. 建立并维护与相关监管机构和认证机构的良好关系。
5. Conduct regular GMP self-inspection and management review, coordinate Baxter internal quality audit and external inspection/audit conducted by authorities, notified bodies and customers. Organize to compile audit report(s) and submit report(s) to relevant organization. 负责组织定期GMP自检和管理评审、协调Baxter内部质量审核，或由监管部门、认证机构和客户等实施的外部检查和外部审核，并负责完成和提交相关报告。
6. Conduct post-market surveillance process including periodic quality reports, distributor quality management process,
负责组织产品上市后监管活动，包括定期的质量报告，经销商质量管理流程，投诉处理，本地召回流程，以及由PV部门支持的药物警戒活动。
7. Responsible for overall CMO quality management process to ensure that CMO’s related process meet the signed Quality Agreement alignment. In addition, maintain the Quality Agreement with CMO.
负责总体CMO质量管理流程，确保CMO的相关活动满足签署的质量协议要求。另外，维护与CMO的质量协议。
8. Establish and maintain Change Control system, NCR, Qualification & Validation system as well as ensure systems operation meeting QMS requirement.
建立和维护变更系统、偏差系统，确认和验证系统，确保系统运行符合质量管理体现要求。
9. Responsible for product release and assure the released product is compliance with related regulations and the specifications. 负责产品放行，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准。
10. Ensure and work in compliance with all EHS aspects. 确保工作符合环保、健康和安全的方针政策。

Qualification:
资格
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 该职位要取得成功，个人应能令人满意地完成各项基本义务。具备所列的知识、技能及要求具备的能力。对能力稍逊者可以适当调整，要求能完成基本的职责。
1. Thorough knowledge of applicable procedures, specifications, regulations and standards.
具备应用程序、规范、法规和标准方面的知识。
2. Good communication and leadership skills
良好的沟通和领导技巧。
Good command of English in listening, speaking, reading and writing.
良好的英语听说读写能力。

Education and/or experience:
教育与/或 经验
Include the education and experience that is necessary to perform the job satisfactorily 为能令人满意地完成工作，应具备的教育与经验
1. Bachelor above in pharmacy or related discipline 药学或相关专业本科以上学历。
2. 5 years above experience in Quality, Manufacturing, Engineering or related field which should include3 years above of quality supervisory experience 5年或以上在质量、制造或相关领域的经验，其中包括3年以上的质量管理经验。

百特是全球领先的医疗用品公司，百特专注于危重治疗领域，在肾科、药物输注和生物科技等领域通过提供先进的多样化的产品和服务，拯救患者的生命并提高患者的生活质量。百特于2005年和2006年连续入选“全球100家最可持续发展企业”。
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，共有正式员工2000余人。
我们的理念是注重结果、客户导向；我们的价值观是正直诚实、坦诚沟通、承责力行；我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业，期盼更多优秀人才的加入，我们承诺为您提供充满活力的工作和成长环境，与百特共筑未来！

广州百特医疗用品有限公司是由百特医疗用品有限公司与广州医药集团合资兴建的企业，是百特在中国***生产治疗肾病的工厂之一，并已于九六年一月开始投放市场，业务遍及国内和东南亚地区，每年的业务均有较大的增长
在百特工作意味着不仅仅是一份工作，而且是一项事业。

广州百特医疗用品有限公司
地址：广州经济技术开发区东基工业区蕉园路
邮政编码：510730
联系人：人力资源部
邮箱：baxter.guangzhou@gmail.com