南通招聘

an Europe API munufacturing company

Key responsibilities:

1．Project phase 项目阶段

· Final reviewing validation protocols, reports, maintenance and calibration of critical equipment and facilities.

最终审查验证方案，验证报告，关键设备和设施的维护和校准。

· Review and approve documents which relevant to quality management systems.

根据相关的质量管理体系审查和批准文件。

· Organize the supplier audit.

组织供应商的审核。

· Carry out the GMP training program for whole company or QA staffs.

推进整个公司或QA人员的GMP培训项目。

2．Operation phase 运营阶段

· Maintain and continuously improve the quality management systems.

保持并持续改进的质量管理体系。

· Finally review completed batch production and laboratory control records of critical process steps before releasing or rejecting all APIs.

在放行或拒绝所有的API之前，最终审查完成批量生产和实验室控制记录关键工艺步骤。

· Releasing or rejecting intermediates for use outside the control of the manufacturing company.

放行或拒绝中间体，使用于制造公司的控制范围之外。

· Maintain a good system to release or reject raw materials, intermediates, packaging and labeling materials.

保持一个良好的制度，放行或拒收原料，中间体，包装和标签材料。

· Making sure that critical deviations, OOS, OOT are investigated and resolved.

确保关键的偏差，OOS，OOT调查及解决。

· Finally review all specifications and master production instructions.

最后审查所有规格和主生产指令。

· Finally review all procedures impacting the quality of intermediates or APIs.

最后审查所有程序，影响中间体或原料药的质量。

· Organize and make sure that internal audits (self-inspections) are performed and all the CAPA are closed.

组织并确保进行内部审计（自查），并关闭所有的CAPA。

· Final reviewing intermediate and API contract manufacturers.

最终审查中间体和原料药的合同制造商。

· Final reviewing changes that potentially impact intermediate or API quality.

最终审查可能影响中间体或原料药质量的变化。

· Final reviewing validation protocols, reports, maintenance and calibration of critical equipment and facilities.

最终审查验证方案，验证报告，关键设备和设施的维护和校准。

· Final reviewing quality related complaints are investigated and resolved.

最终评审质量相关的投诉进行调查和解决。

· Checking all materials are appropriately tested and the results are reported.

检查所有的材料适当地测试，报告结果。

· Ensuring there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate.

确保有稳定性数据支持原料药和/或中间体在适当的情况下的复验期或有效期和储存条件。

· Organize the product quality reviews.

组织产品质量检验。

· Review and approve documents which relevant to quality management systems.

根据相关的质量管理体系审查和批准文件。

· Organize the supplier audit.

组织供应商的审核。

· Carry out the GMP training program for whole company or QA staffs.

推进整个公司或QA人员的GMP培训项目。

Critical Experience and Skills/关键技能和经验

· Pharmaceutical or chemical degree or similar back ground (bachelor or above)

药物或化学或类似学历背景（本科或以上）

· More than 5 years’ experience in API quality management related job (with the experience in API workshop management or foreign company’s experience is priority)

5年以上API质量管理有关的工作经验（原料药车间管理经验或外资公司经验优先）。

· Have the experience of participation the GMP inspection from FDA, EDQM, SFDA or other stringent regions.

有参与FDA，EDQM，国家食品药品监督管理局或其他严格地区的GMP检查经验。

· Experience of working in an international team.

有国际化团队的工作经验。

· Good oral and written English skill

良好的英语说和写的能力。

Personal Skills/个人技能

· Strong team player

良好的团队合作精神。

· Self-motivator with ability to work independently

自主工作与独立工作的能力。

· Creative and solution orientated approach to issues resolution.

具备创新和结果导向的解决问题的能力。

Report to /汇报对象

· Compliance manager

合规经理

Subordinate (directly)/直接下属

· QA Specialist

QA专员

· Validation Engineer

验证工程师

· Compliance Engineer

合规工程师

汇杰(Resourceful)于2004年成立，总部位于苏州，是一家专业的招聘咨询服务公司，专注于为企业提供中高级专业人才招聘解决方案，在工业制造、教育、医药医疗等行业是汇杰的强项。服务覆盖中国大陆地区主要城市。