职位描述

职位描述： 职责范围：1.过程控制：组织并协调按照规程对生产设施/设备进行生产前检查，对车间生产进行中间控制检查；保证生产活动符合GMP标准。组织并协调异常情况的处理。In-process control:To organize and coordinate start-up inspection for manufacturing facilities/equipments, in-process inspection according to plant procedure to ensure that production activity compliance with the GMP.To organize and coordinate the handling of abnormalities during production.2.文件审阅：组织并协调对样品信息和过程控制检验结果的录入和复核等其他操作；审核产品批生产文件。Document review: To organize and coordinate entering and reviewing or other operation of sample information and in-process tests results; Review batch record.3.包材检验：组织并协调按规定对包装材料Artwork进行审核和色卡、条码的批准。对包装材料进行取样和检查，协调及保证包材的及时发放，并将与包材或其他物料有关的质量问题对供应商进行投诉和沟通。Test of Packaging Materials:To organize and coordinate reviewing of the Artwork of Packaging material and approving of color swatch and bar code. To conduct sampling and testing of Packaging material, coordinating and ensuring timely releasing of packaging material.Conduct Quality complaint to and communicating with supplier about quality problem for packaging materials or other materials.4.半成品发放和包材发放、物料编码签发：组织并协调对产品生产过程文件进行审核，经过半成品发放的全面培训后，可以进行半成品的发放。协调完成包装材料的发放。Release of semi-finish good and packaging material and issuing of material Code No.: To organize and coordinate reviewing of production in-process document, it is allowed to perform semi-finish good release after entirety training. To coordinate releasing of packaging material.5.规程起草和修订：组织并协调规程及包材相关质量标准和检验方法的起草和修订。完成相关的数据整理、文件管理及归档工作。Drafting and revising of Procedure:To organize and coordinate drafting and revising of procedure, quality specification and test method of packaging material.Complete related data sorting， document managing and filing.6.偏差调查：组织并协调进行偏差的调查和处理。Deviation investigation: To organize and coordinate investigating and handling. 7.质量体系：？文件的管理： PDOCS系统的管理和工厂文件的签发。？投诉：主导对客户投诉的处理，负责PCOM系统的管理。？供应商管理：维护合格供应商清单和文件，参与供应商审计和评估。？培训：配合培训负责人管理工厂培训系统和PLS系统管理。？质量追溯： QTS系统管理。保证所有的生产调查，变更，CAPA和实验室偏差的完整性和SOP符合性。？内外审计：参与内部质量保证审计、外部供应商审计？退换货：主导并协调对客户退货进行处理。？验证：验证计划和验证体系的管理？变更：主导变更工作的评估和实施。Quality system:？Document management: Responsible for PDOCS system and all documents distribution.？Complaint: Responsible for customer’s complaints and PCOM system management.？Supplier management: Maintenance qualified supplier list and documents. Supplier audit and assessment.？Training: cooperate with Training Lead to manage the training system and PLS system.？Quality tracing: Responsible for QTS management and ensure all MIR/LIR/CAPA/CC are completed and compliance with SOP.？Inner/outer audit: Dominate internal QA audit and external supplier audit.？Validation: Responsible for leading site validation work and validation system management.？Changing or Returning: Dominate and coordinate the dealing of products returning.？Change control: Dominate assessing and implementing of change control. As Compliance Network Member, QA need ensure effectively tracking all quality and regulatory changes and ensure effective the regulatory changing communication with WRS team.8.培训：组织并协调对相应人员做质量控制和质量保证相关的培训。Training: To conduct quality control and quality assurance related training to corresponding persons.9.QA系统管理：负责完成计算机系统的工厂质量管理。QA System management：Responsible for the quality computer systems management at site level.10.完成上级安排的其他相关工作。Complete other related work assigned by QA supervisor.教育程度/经验Education Background/ Experience1．大学本科及以上学历，药学/药物分析/化学分析/化学等相关专业；Have a Bachelor''s degree or above, related major of pharmacy, pharmaceutical analysis, analytical chemistry or chemistry etc.特别知识Special Knowledge掌握辉瑞质量管理系统，国家GMP及相关药政法规。Master PQS, GMP and related regulations.技能Skills:1.具有良好的英语综合能力及计算机应用能力；Have good English and computer application ability.2.具有团队合作精神，工作责任心强；To be cooperative and have sense of responsibility.3. 具有一定的沟通协调能力和培训能力。Have capability of communication and training. 职能类别： 药品生产/质量管理

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