职位描述

职位描述： 主要职责 Role Responsibilities· 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。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.· 负责及时发现生产线在线问题并进行上报，并对生产或产品作出紧急处理建议，确保潜在问题产品可控，不会流入下道工序。Responsible for timely identify the online problem, give immediately disposition suggestion, ensure the issue product under control on-line problem in a timely manner when it presents, to ensure product quality and compliant with cGMP and PQS requirement.· 负责工厂物料放行，建立物料质量投诉管理体系，以确保物料持续符合GMP要求及质量标准的。包括但不限于：原辅料内包材等关键物料的放行；入厂后发现的物料问题处理；建立并管理物料供应商投诉体系；建立并管理物料表现数据库并跟踪供应商问题调查，审核供应商调查报告及整改行动计划。Responsible for material release, establish and administer material complaints management procedure, ensure materials continually meet cGMP requirements and quality specification are release for production. It includes but not limited to: Raw material and excipient and other controlled material release; material quality issue handling; establish material performance database and material complaint system; Follow up on supplier investigation progress; review supplier investigation report and CAPA。· 参与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；Participate in site deviation/complaint investigation and perform impact assessment, participate in CAPA initiation and effectiveness check;· 协助执行年度产品质量回顾；对原料部分进行年度回顾并识别改进机会。Assistant of annual product quality review; perform annually review on material related section and identify improved chance.· 参与公司验证活动，确保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。Participate in 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.· 建立物料和产品的取样留样体系，并作为取样室、留样室的责任人进行日常管理，包括但不限于：物料及产品的取样流程、取样方法、取样工具管理、留样管理流程等；Establish material and product sampling procedure, responsible for routine management of sampling room and retention room, it includes but not limited to: material and product sampling procedure, sampling methods, sampling tools management, and retention sample management.· 作为审计支持人员参与质量审计工作的准备，如资料的收集及审核等;Responsible to support quality audit readiness，e.g. supporting document collective and review;· 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3年或以上的制药企业质量相关工作经历，有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 3 years of working experience in Pharmaceutical Quality, working experience in Biologics, Sterile and Aseptic Manufacturing is preferred. 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；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。Proficient in using English as working language at listening, speaking, writing and Proficient in Microsoft Office application; Fully capable of establishing GMP Quality Management System; Effective Systematical Thinking and Communication ability; Good Coordination 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

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