职位描述
Job Purpose工作目的
1. The role is responsible for batch document reviewed timely, perform QA oversight in PU, and assure that Products’ production activity complies with Novartis Quality Policy and GMP requirement.
负责批文件的及时审核，实施现场检查，并确保生产过程符合诺华质量手册和GMP要求。
Major Accountabilities 主要职责
Principal Job Objectives 主要工作目标
1. Review Batch Document and records timely and ensure that the following requirements have been met：
及时审核批文件和记录并确保满足以下要求：
1） All the necessary checks and tests have been performed. 确保所有必要的检查和测试已经实施。
2） Review QC testing record and confirm that QC report had been approved by coordinators trained in appropriate disciplines and the product quality conforms to specifications.
审核QC检测记录并确认QC报告已经由培训过的协调员批准并确认生产的产品符合规定的质量标准。
3） All necessary production documentation has been completed and endorsed by coordinators trained in appropriate disciplines and confirm that batch manufacturing activities are in compliance with Novartis quality policy, local regulatory and GMP requirements.
所有必要的生产文件已完成且已经由培训过的协调员核准过, 并确认生产过程符合诺华质量手册、本地法规和GMP要求；
4） The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned; 确保批次产品符合市场准入要求和生产合规要求；
5） The principles and guidelines of GMP, as laid down in the guidelines published by HA, have been followed; 确保遵循卫生管理部门颁布的GMP原则和指导方针；
6） The principal manufacturing and testing processes have been validated, if different; 关键生产工艺和检验方法变更时要经过验证；
7） Any changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any product is released; 在产品放行前，任何生产或质量控制中变更和偏差需要通过健全的系统来进行汇报和评估；
8） All relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs). 审核批文件要考虑所有相关因素，包括与产品没有明确关联的因素（例如正常批次的分批，连续生产批次的影响因素）。
2. Master document updated
主文件的更新
Review master document (E.g.: MBD, MCR and MBR, etc.) timely, and assure that master document complies with requirement of validation protocol, registration file, etc.
及时审核主文件（例如：主文件，主清洁记录和主批报等），确保主文件符合验证方案和注册文件等相关的要求。
3. Document archived:
文件存档：
Safely archive relevant Documentation(e.g.: Batch Document, Cleaning Record, Master Batch Document, Master Cleaning Record, etc.）for the prescribed date.
确保质量相关文件(例如：批记录，清洁记录，主批文件，主清洁记录等)安全地在规定时间内均被存档。
4. QA Oversight:
QA 监管:
GMP monitoring, perform the oversight review as shift QA, escalate timely and push correction or follow up related corrective action.
生产GMP现场监控，作为倒班QA执行生产现场检查，并及时汇报，推动和跟踪相应的整改活动。
5. Training:
培训：
Complete individual training according to Individual Annual Training Plan, and other training.
根据个人年度培训计划完成个人培训和其它培训。
6. Oversee the execution of in-process control
监督中间控制的执行和评估
1) Understands the related products efficacy, property and test points which should be paid special attention.
Understands information of product quality reflected from test results.
了解各产品特性及测试关注点，理解中间控制各项测试的原理和目的。理解测试结果所反映的产品质量信息。
2) Review relavant logbook used in IPC.
审核中间控制过程相关日志。
3) Monitor the operation of in-process control complies with approved test method.
监控中间控制操作过程符合批准的方法要求。
7. Other：
其他：
1） Complete CAPA timely which triggered from deviation, internal audit or other external audit.
及时完成由偏差，内部审计或其它审计产生的整改措施。
2） Perform change request releted evaluation.
执行变更相关的评估。
3） Provide effective compliance supporting and services to others.
为其他部门提供合规方面的有效支持和服务。
4） Assist QA investigation for noncompliance. 协助 QA进行不合规方面的调查 。
5） Give basic training for PU employees as the purpose of RFT of batch document improvement. 提供基础培训，以提高PU操作人员批文件一次合格率。
6） Attend to any other work related assignment, which may be given by the superior. 完成上级指定的其他工作。
7） Monitor effectiveness of quality systems within the PU.监督运营部门质量体系的有效性。
Key Performance Indicators 绩效考核指标
1. Review batch documents and cleaning record and ensure quality of BD/CR. 审核批文件及清洁记录，保证批文件及清洁文件的质量。
2. Review MBD/MBR/MCR and ensure quality of MBD/MBR/MCR. 审阅主批文件\主批报\主清洁记录，保证主批文件\主批报\主清洁记录的质量。
3. Perform QA oversight following project time line and push correction or follow up related corrective action. 按计划对生产过程进行监督，推动和跟踪相应的整改活动。
4. Support audit when necessary and ensure no critical or major finding during audit. 在审计中提供必要的支持， 并且确保没有严重或主要发现项。
Ideal Background 理想的背景
Education:教育
Bachelor degree above本科及以上学历
Languages:语言
Fluent in spoken, written, listening and reading English and Chinese中、英文听、说、读、写熟练
Experience:工作经验
2 years’ experience in Pharmaceutical Industry2年以上药厂工作经验
