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| Position |
RC & QMS Manager法规和质量体系经理 |
| Company Info |
An European Company |
| Responsibilities |
Job Purpose and Key Responsibilities 岗位的目的和主要岗位职责:
Job Purpose 岗位目的:
l 负责QMS在工厂内的推行。
Responsible for QMS implementation in the site.
l 在所有GMP流程的审计中确保持续的GMP和法规的符合性。
Assure continuous GMP, Regulatory & Corporate compliance through audits of all GMP processes
l 沟通和解决影响产品质量、安全/效期、法规符合性或商业持续性的事宜。Identify and communicate any issues that impact product quality, safety or efficacy, regulatory compliance or business continuity.
l 领导、管理或支持法规检查的准备，确保整改预防措施在TSKF的落实。
Lead, manage or support, regulatory inspection preparation and assure corrective actions and strategies are implemented at TSKF.
l 参与和推动工厂内质量体系的持续发展。
Participate in and where necessary drive the continuous improvement of the quality system throughout the site.
Key Responsibilities主要岗位职责:
∙负责公司的GMP审计。
Lead GMP Audits.
∙与上级领导者和关键管理者沟通有重大质量风险的关键事宜。
Communicate critical information regarding significant quality risk to senior management & Key Stakeholders
∙制定需要达到和/或维护可接受的质量标准的行为，这是质量需求平衡/可用资源成本意识的主要因素。
Propose actions required to achieve &/or maintain acceptable quality standards. This information will be a major factor in balancing Quality requirements / Cost awareness with available resources.
∙改进公司GMP自检/内审的实施和工作方式。
Develop GMP self inspection/internal audit practices & ways of working at TSKF
∙建立并维护与TFDA及天津市药品检验所良好的合作关系。
Establish and maintain good relationship with Tianjin FDA and Tianjin Institute for Drug Control.
∙维护与ARM质量的紧密联系以确保质量的标准化。
Maintain close contact ARM & GSK corporate Quality to assure standardization of quality.
∙领导、管理或支持所有法规检查的准备行动。
Lead, manage or support all regulatory inspection preparation activities.
∙建议和纠正整改预防措施，以保证其被落实和追踪。
Propose and co-ordinate corrective actions. Assure that corrective actions are implemented and tracked.
∙确保原料和成品的标准和测试方法符合许可证和其他相应标准。
Ensure that factory specifications and test methods for raw materials and finished products are in compliance with licences and other appropriate standards.
∙确保可能对产品质量有重大影响的GMP偏差及时告知OQ管理者和价值流经理。
Ensure the OQ Manager and Value Stream management are notified of any deviations from GMP which may have a significant effect on product quality.
∙管理符合性行为（EHS和GMP）和方式，确保操作被有准备的检查。
Manage activities in a compliant (EHS and GMP), manner and ensure operations are inspection ready.
∙提供GMP和相关QMS培训，对新员工提供入职GMP培训。
Deliver GMP and relevant QMS training. Delivery GMP training to new staff.
∙确保一切变更均经过适当的验证和有文件记录，从而与被批准的公司流程相一致。
Ensure any changes have been appropriately validated and documented in accordance with approved TSKF processes.
∙QMS符合性的推动，差距分析和结果追踪，包括相关风险评估和管理。
Push the QMS compliance progress, organize the gap analysis and action tracking in the site, including the risk assessment and management.
∙制定周期性内部审计计划，保证按时完成审计任务。追踪整改预防措施的落实和及时关闭。批准和拒用供应商，依据审计结果和供应商绩效。
Issue periodical internal audit plan, ensure finish task on time. Follow up corrective action and make it close on time. Approval/reject supplier/third party according to audit results and their performance.
∙质量相关培训和法规的采集、沟通和跟进。
In charge of the Quality training and regulatory filing, communication and compliance follow up.
∙负责准备和接待法规审计以及集团内审，提交针对性整改措施并录入CARISMA, 追踪承诺并保证及时关闭。
Lead the team to prepare for regulatory audit and level 3 GQA audit, issue relevant corrective and key in CARISMA system. Follow up commitment and make it close on time.
∙负责审核所有变更。处理变更控制及后续行动的追踪，确保生产流程符合注册细节。
Review all change controls in TSKF. Coordinate the change control, customer complaint and track the action, ensure production processes comply with registration detail.
∙负责TTS的起草和更新。
Coordinate the TTS approval and on time refresh.
∙负责月度Quality Council的协调
Coordinate the monthly Quality Council.
§ 负责印字包材的审核及TFDA批准后在TSKF的实施
Review art work and in charge of implementation in TSKF after Tianjin FDA approval.
∙激励和辅导下属完成部门目标，确认适当的培训需求，实施培训计划。
Motivate and coach the subordinate to complete the team objective, confirm proper training plan.
Comply with site SOPs on environmental health and safety.
遵守公司关于环境、健康与安全方面的要求。 |
| Requirements |
Specialised Knowledge 专业知识:
· 文化程度(学历/专业) Degree
大学本科或以上毕业，药学或相关专业毕业；
Bachelor and/or above, Pharmacy or related.
· 任职经验Experiences
6年以上相关工作经验，具有至少4年质量领域的管理经验
More than 6 years experiences, 4 years management experiences in Quality area at least.
· 专业知识/技能 Technical talent
了解质量组织，熟悉QMS系统Familiar with GSK quality organization and QMS.
熟悉报告系统/衡量系统/质量审计系统 Familiar with the GSK report system/measurement system/Audit system
熟悉相关国家和地方质量政策法规(GMP，GSP，药监，药检等) Familiar with relevant National and local quality regulation.( GMP, GSP, SFDA, IDC)
通晓公司相关质量规程/SOP/所有质量标准 Familiar with TSKF Quality system/SOP/Specifications
具备药品验证理论知识和经验，熟悉质量管理工具的应用 Familiar with validation theory and experience and the quality tools implementation.
具有质检或相关证书 Certificate of QA
· 计算机及外语水平 Computer and English level
电脑及业务软件的使用能力 Familiar with the Office software and other professional software.
英语水平较好(会话、阅读相当于6级) English level CET-6 for oral and reading ability.
· 能力要求 Professional
良好的职业道德，诚信、正直、认真、坚持原则 Well occupational moral, Honest, persist in the principles.
高度的质量敏感性 High sensitivity of Quality
较强的沟通、协调，组织，领导，创新能力 High ability of communication, coordination, leading and creation.
较强的分析判断解决问题能力 Good ability of analysis and judgment.
较好的书面报告能力，较强的学习能力 Good ability of report and learning. |
| Update |
2014-09-26 |
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