CLIENT PROFILE

 

我们的客户是一家美资知名生物制药企业，在上海开办的分公司迄今已有20多年。公司规模较大，其业务主要覆盖在大中华地区，在国内各大城市拥有多家独资或合资企业。公司业务包括多类固体制剂、生物制剂的研发、生产、销售、进口，主要产品包括一些天然产品提取物及其合成类产品，同时也会涉猎环保科技和高科技化工等多个领域。

 

Position: QA Officer / Assistant

 

Basic Job Purpose:

• Create, check and approve documents within the Hygieia QMS system and maintain the appropriate quality related fields/areas in the MRP system (Pronto).

建立与审阅澳大利亚业务相关质量体系文件，维护Pronto系统内的有关质量数据

• Maintain and administer Hygieia’s Quality Management System (QMS). E.g. change control, SOP’s, unified specifications, raw material specifications,  deviations, non-conformances, corrective actions, customer requests and complaints, GMP agreements, MMF’s, vendor assurance etc for the Australian business..

维护和管理公司澳大利亚业务相关的质量体系，例如：变更控制、SOP、质量标准、偏差处理与整改措施、客户需求与投诉、GMP协议、生产主文件、供应商管理等

• Assure that Hygieia and the OEMs comply with all requirements of the codes of GMP, quality and good business practices as applicable to the purchase and supply of raw materials, bulk products, QA/QC services and warehousing etc. for the Australian business.

确保加工澳大利亚产品OEM工厂在原物料供应、仓储、产品放行、QA/QC服务等方面的质量符合澳大利亚法规的要求

Key Accountabilities:

• Administer the various documentation systems.

管理各种体系文件

• Create, maintain and supersede all quality related documentation in a timely and clearly traceable manner.

以及时、清晰及可追溯的方式建立、维护和更新所有质量相关文件

• Manage the process to ensure that all documentation gains appropriate Sponsor approval as required.

确保所有文件按照需求经过相关责任人的审核

• Ensure that all required documentation (e.g. specs, SOPs etc) is appropriate, current and available to the employees as needed.

确保所有必须的文件（如质量标准、SOP等）能及时有效地提供给需要的员工

• Provide leadership for management of GMP and quality.

提供GMP与质量管理方面的支持

• Manage aspects of the overall QMS compliance requirements of the Hygieia and OEM sites - these include:Customer Complaints,Customer Requests/Enquiries,Non-compliance,GMP agreements,Vendor Assurance;

海吉亚和OEM工厂的全方位质量体系法规符合方面的管理，包括：客户投诉、客户需求/查询、不合格调查、GMP协议、客户保证；

 

Key Selection Criteria:

 

Qualifications/Experience:

• Degree in Applied Science (Chemistry, Pharmacy).

化学、药学或相关专业大专以上毕业

• Minimum 1 year in quality management in a pharmaceutical QA or Manufacturing environment.

一年以上制药领域QA或生产工作经历

 

Personal Qualities:

• Attention to detail  关注细节
• Negotiation skills  谈判技巧
• Management skills  管理技能
• Conflict resolution  解决冲突
• Commercial view of quality  质量的商业考虑
• Leadership  领导力
• Report writing  书写报告
• Communicator  沟通交流
• Takes initiative  工作主动性
• Problem Solving  解决问题

 

Please send your updated CVto:r.chen@excelhro.com