Overview
GMP QA Jobs in Shanghai, Shanghai, China at 迪哲(江苏)医药股份有限公司
Title: GMP QA
Company: 迪哲(江苏)医药股份有限公司
Location: Shanghai, Shanghai, China
该职位来源于猎聘
Job Purpose 工作目标
This role is to establish/maintain QA procedures covering from product development to manufacturing to ensure compliance with the applicable cGMP and regulations, as well as provide QA professional support to assigned clinical projects/product as SPOC to ensure controlled product quality and timely delivery. 该角色负责建立/维护产品研发和生产QA 流程，确保符合cGMP和相关法律法规。同时 作为临床阶段质量部单点联系人提供QA的专业支持，确保产品质量可控，且按时交付。
Roles & Responsibility 主要职责
Manage QA Aspects In Contract Manufacturing Organizations And Dizal Internal For API And DP Development, Clinical Production, Validation And Commercial Manufacturing, To Assure Product Quality And Patient Safety, Including But Not Limited To
负责制剂和原料药的开发，临床生产，验证和商业化生产在委托生产方及迪哲内部的质量管理活动，确保产品质量可控和患者安全，包括但不限于：
- Act as SPOC of the assigned projects/product for internal stakeholders and external CMOs.
作为指定项目/产品在迪哲内部以及外部委托方生产方的单点质量联系人。
- Review of batch release profile to assure that the batch of product meets specifications and requirements and can be released to commercial distribution. This review involves documents such as batch records, deviations, investigations, laboratory results. In cased where there are deviations, there must be assurance that they have been fully investigated and effective corrective and preventative actions (CAPAs) have been identified and put in place. Release or reject APIs and drug products produced by the contract manufacturer.
审核产品批档案文件以保证放行的产品符合其质量标准。审核的内容包括批记录（生产和检验记录），偏差，调查和实验室测试结果。如果有偏差出现，需对其进行全面的调查并落实相关的整改措施。放行或拒绝由合同生产方生产的API和制剂成品。
- Supervise contract manufacturing activities, sustain the compliance with requirements of GMP regulations, NDA and Post-Approval files. 监督委托生产方的生产和检验活动符合GMP法规，NDA及上市后变更文件要求。
- Provide professional quality support and review and approve product quality related document, e.g quality deviation/OOX and investigations, CAPA, change management, complaints, recall, process and method validation documents, quality test methods and specification, annual product review, disposal of returned and rejected goods, etc. 提供质量专业的支持以及质量文件的审核和批准，包括质量偏差/超标超限异常和调查，纠正预防措施，变更管理，投诉，召回，工艺及方法等验证文件，分析方法和质量标准，年度产品回顾，退货和不合格品处理等。
- Responsible for the whole quality lifecycle management of contract manufacturers and suppliers, including audit and evaluation of supplier, negotiation and updating of Quality Agreement, quality risk assessment, quality meeting, quality review and improvements, to ensure compliance with Dizal’s quality system requirements. 负责委托生产方和供应商质量全生命周期管理，包括供应商审计和评估，质量协议沟通及更新，质量风险评估，质量会议，质量回顾和改进等，确保符合迪哲质量体系要求。
- Responsible for conducting qualification assessments of suppliers to ensure their capabilities in quality assurance, quality control, and risk management in GMP-related activities, as well as overseeing their performance. This includes participating in the investigation, handling, and communication of quality events related to Dizal’s products, and reviewing or approving documents/records from contracted parties. 确保供应商GMP相关业务的活动中质量保证、质量控制和风险管理的能力，并对其进行监督管理，包括参与迪哲产品相关的质量事件的调查处理和信息沟通，并对合同方相关文件/记录进行审核或批准。
- Responsible for the review of specification establishment, quality control test and stability study of all components of commercial medicinal products including APIs，excipients, packaging materials, in-process materials, and drug products.
负责已上市商业化产品中所使用的原料药，辅料，包装材料，半成品，制剂成品的质量标准、质量控制测试和稳定性研究的审核。
- Responsible for commercial phase analytic method development，validation, verification, and transfer review. 负责商业化阶段的分析方法开发、验证、确认和转移的审核。
- Review the analytical documents including protocols, reports, notebooks and raw data from contractor to ensure the analytical data integrity and accuracy.
审核商业化产品的方案、报告、记录和原始数据等分析文件，确保分析数据完整性和准确性。
- Review testing records of contract manufacturer/lab to make sure the right specifications are applied and the test data are correct, supervise and manage the implementation of the quality control activities and laboratory management, and review/approve the documents and records related to quality control to ensure GMP compliance and Data Integrity.
审核合同生产方/合同实验室的批检验记录以保证使用正确的质量标准和测试数据无误，并对其质量控制活动和实验室管理的执行进行监督管理，进行质量控制活动相关的文件/记录的审核或批准，确保其符合GMP规范和数据可靠性。
- Maintain and supervise effective execution of quality risk management procedures. 完善和监督质量风险管理的有效执行。
- Provide quality support and review and approval of quality document for investigational medicinal product labeling and distribution and clinical use.
负责临床试验用药物贴签和运输，以及临床使用的质量支持及质量文件审核批准。
- Review and approve clinical label and commercial artwork. 审核和批准临床标签及商业化印字包材。
- Provide quality support for API & DP technology transfer to ensure necessary knowledge and experience well exchanged. 提供原料药和制剂技术转移的质量活动支持，确保必要的知识和经验能够很好的交流。
- Support inspection and readiness program in various countries , support compliance activities for successful NDA filing, product launch and routine supply. 支持各国的检查准备和现场检查，支持新药注册，产品上市及日常供应的合规。
- Establish and review quality system procedures, system annual trend or report, and participate in self-inspection. 创建和审核质量体系程序、体系年度趋势或报告，参与质量内审和自检。
- Manage and implement GMP QA process to ensure the fulfillment of product quality requirements according to corresponding standards and regulations. 管理和执行QA流程，确保产品质量达到标准和法规要求。
- Provide QA review of CMC part in NDA submission.
NDA申报CMC相关部分QA审核。
- Promote and implement the continuous development and improvement of Quality Assurance for investigational projects and commercial production. 推动并执行在临床项目及商业化生产质量保证的持续发展和改进。
Job Requirement 工作要求
- Minimal Bachelor degree in Pharmacy, Biology, Chemistry, or related fields. 至少本科或以上学历，药学，生物学，化学或相关专业 。
- Minimum 5 years of experience working in pharmaceutical or biotechnology industry GMP experience in a quality and manufacturing function. 5年以上制药或生物技术行业在质量和生产部门GMP工作经验。
- Familiar with finished product or API manufacturing process and equipment. 熟悉制剂或原料药生产工艺和设备。
- Good communication and ability to address, investigate, and solve problems. 良好的沟通和处理、分析问题的能力。
- Continuously invest time and effort to gain new skills and knowledge required to succeed in work. 持续的学习能力获得新的知识或技巧以胜任工作的要求。
- Good English and Computer skill.
- 英语水平良好，电脑使用熟练。Willing to travel approximately 5 – 10%. 愿意出差大约5 – 10%。
