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5-7年经验 -
本科 -
招若干人 -
11-09 发布
职位描述
职位描述： 主要职责 Role Responsibilities· 维护及优化生产批记录审核流程，并负责生产批记录及支持文件的审核，确保生产主批报以及批记录符合产品工艺规程，注册工艺，cGMP，以及PQS的要求。Maintain and optimize production batch record review procedure, and is responsible for batch record and support document review, to ensure production master batch sheet and batch record is consistent with product process description, registered process, and compliant with cGMP and PQS requirement.· 负责配液，原液生产，灌装，包装，外观检查等生产工序的监督管理；在线问题的处理，在收到生产线质量相关问题的报告时，负责及时有效地对生产或产品作出正确的处理，保证产品质量，并符合cGMP和PQS的要求。Responsible for surveillance of production process e.g. compounding, drug substance, filling, packaging and inspection, and effectively handle on-line problem in a timely manner when it presents, to ensure product quality and compliant with cGMP and PQS requirement.· 主导工厂偏差及投诉调查、影响评估，参与CAPA制定及有效性确认，并审核调查报告；负责事件/偏差/投诉的定期趋势回顾以及持续改进；Lead site deviation/complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check; Trends analysis for deviation/quality complaint and continuous improvement etc.;· 制定年度产品质量回顾计划；按计划实施年度产品质量回顾；趋势分析并及时采取有效措施等。Develop annual product quality review plan; perform product quality review as planned; trends analysis and take necessary CAPAs etc.· 负责工厂设备/工艺的验证管理，确保公司验证活动符合法规要求以及PQS要求。包括但不限于：审核验证方案及验证报告，作为质量代表参与验证过程的实施并审核验证偏差。根据验证结果的输出，对后续行动进行追踪有效实施。Management of plant equipment/process qualification/validation, ensure validate activities compliant with cGMP and PQS requirement. It includes but not limited to: Review qualification/validation protocol and report, participate in validation process and review deviation during validation；follow up on the validation output to ensure the relevant activities carry into execution.· 审核工艺/设备相关的WI，包括但不限于：设备操作、工艺描述、清洗消毒、生产区物料管理等； Review process/machine related WI, it includes but not limited to: machine operation, process description, sanitization, material handling in operation area etc.· 管理工厂物料质量控制体系，以确保只有符合GMP要求和质量标准的物料才能用于生产。包括但不限于：物料接收、存储、取样、放行、状态控制、不合格物料管理、退货等流程管理；审核物料质量标准。Management of material quality control system, to ensure only materials that meet cGMP requirements and quality specification are release for production. It includes but not limited to: manage material receiving, storage, sampling, release, status control, material release, unqualified material control, returned goods manage; review material quality specification.· 参与公司审计准备以及审计支持，包括但不限于：作为审计人员参与公司内审活动；作为审计支持人员进行公司内外审的准备以及应对；支持有工厂负责的供应商审计等。Participate in company audit readiness plan, It includes but not limited to: act as auditor to perform internal audit; act as auditee to support internal/external audit; support plant performed supplier audit.· 营造合作、开放、合规的质量文化；作为质量部代表参与生产部的沟通会，分享质量绩效，及时了解生产部门所需的质量协作并提供有效的支持，确保与生产部门的有效的沟通。Create Cooperative, Open and Compliance working atmosphere; act as quality representative to participate in the communication meeting of operation department and share the quality performance, acknowledge of assistance need from quality and provide relevant support, keep effective communication with OPS department. · 执行公司安排的其他相关工作。Execute any other related work assigned by company.任职资格 Qualification (最低任职要求 Minimum Requirements)· 教育程度/经验 Education/Experiences- 具有生物学、药学或化学等相关专业本科学历；具有5年或以上的制药企业质量相关工作经历，其中3年或以上生物制药以及无菌生产相关工作经历； 熟悉掌握GMP知识及其应用。- Pharmaceutical, Chemical or Biological related Bachelor Degree; No less than 5 years of working experience in Pharmaceutical Quality, at least 3 years of working experience in Biologics, Sterile and Aseptic Manufacturing. Proficient in GMP related knowledges;· 特别知识/技能 Specific Knowledge & Skills- 生物制药和无菌生产相关GMP知识。Biologics and Sterile/Aseptic manufacturing related GMP knowledge;- 熟练的英语听说读写能力和计算机office软件应用能力；熟悉GMP管理体系的建立；熟练的沟通技能和团队协作能力；有效的执行力和达成结果的能力；熟悉掌握分析问题、解决问题以及质量风险管理的理论及其工具；无菌工艺产品质量处置能力。Proficient in using English as working language at listening, speaking, writing and Proficient in Microsoft Office application; Familiar with establishing GMP Quality Management System; Good Communication and Collaboration; Effective execution and result driving; Good at Problem solving and Quality Risk Management knowledge and Tool application; Sterile and Aseptic product quality disposition ability. 职能类别： 药品生产/质量管理
联系方式
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公司信息
辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球最大的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。 我们的目标是“ ”。我们的使命是“ ”。 2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。 目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。 在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。 辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。 辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。 辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。 At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.
