QA – Technical Services(10-20万)

职位摘要

行业类型

生物制药

招聘人数

1

职位性质

全职

工作地点

上海

薪酬范围

10-20万

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我司正在为某世界前10名制药公司招聘以下职位:QA – Technical Services
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职位概要 Job Highlights:

罗氏是著名制药品牌,其质量管控体系在业界受到一致的认可可以接触到各个环节的质量,成为质量方面的专家,职业发展路径更宽

职责描述 Key Accountabilities:

Execute QA oversight of the Engineering department including FIT walk-throughs, calibration and preventative maintenance program and work order process
对工程部门进行质量检查监督,包括FIT检查,校准和预防性维护计划和工作流程

Execute QA oversight of Warehouse Operation & Transportation where applicable
在适用的情况下实施仓库运营和运输的QA监督

Execute QA oversight of QC lab
在QC实验室实施QA监督

Responsible for escalation of significant quality issues following the criteria as defined in the current governing documents
负责按照现行管理文件规定的标准对重大质量隐患进行升级上报
Execute QA oversight of QC labs, Engineering including deviation, change control, PM & calibration etc.
实施QC实验室和工程的质量保证监督,包括偏差,变更控制,PM&校准等。

Execute frontline QA activities in QC and Engineering
实施QC和工程的前线质量保证活动
Oversee Environment monitoring, Potable & PW system monitoring program
监督环境监测,饮用水和纯化水系统监测程序

Oversee product transportation, including
监督产品运输,包括
Logistic Service Provider audit & supporting bidding
承运商审计&支持招标
Shipping temperature assessment
运输温度评估
DMS & CAPA handling
DMS和CAPA处理

Oversee Facility & Utility related investigation such as EM & Water discrepancies
监督设施和公用事业相关调查,如EM和水的差异
Collaborate with SMEs and Lead investigators to develop investigation strategies
与主题专家和牵头调查员合作制定调查策略
Participate in Local CAPA Review Board and Quality Council when needed
必要时参加当地CAPA审查委员和质量委员会
Monitor investigation progress and ensure effective corrective and preventive actions are initiated and executed on time
监测调查进度,确保及时发起和执行有效的纠正和预防措施
Keep continuous improvement
持续改进

Ensure QA process/documentation in a continuously compliant state and a continual state of readiness for regulatory agency inspections
确保质量保证流程/文件处于持续合规状态,并保持可随时接受监管机构检查的状态
Execute product recall & mock recall
负责产品召回和模拟召回
Execute product return, material destruction
负责产品退货,物料销毁
Provider IT super user service (SAP, MES and ALPIN system) to cooperate in quality related activities completion
提供IT超级用户服务(SAP,MES和ALPIN系统),合作完成质量相关活动
Provide supporting/service to operational QA SOP maintenance, document archiving and management
为运营QA SOP维护,文件归档和管理提供支持/服务
Support management of direct material, suppliers and service providers
支持直接物料,供应商和服务提供商的管理
Support regulatory inspections and partner audits
支持监管检查和合作伙伴审核

Inform Quality Management about significant issues that require escalation according to the internal requirements
对于需要进行升级上报的重大隐患,根据内部要求通知质量管理层

Complete other tasks assigned by senior leaders
完成上级领导交办的其它任务

Key Interfaces:
Manufacturing, Engineering, Local MSAT, Planning, Warehouse, Safety
生产、工程、本地MSAT、计划、仓贮、安全
Cross-site and global BPms
跨工厂和总部BPms
PQS document owners/authors (PTQG)
PQS文件负责人/作者(PTQG)

职能需求 Competence Profile:

●Experience (may vary depending on site size/scope)
经验(基于工厂规模和范围可适当调整)
7 or more years’ work experience in the pharmaceutical or related industry
7年以上制药或相关工厂工作经验
3 or more years’ experience in a commercially licensed GMP facility
3年以上GMP工厂经验

●Knowledge/Skills/Competencies
知识、技能、能力
Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry
质量体系及在药厂质量保障原则、操作模式及标准 的专家
Expert knowledge of cGMP relevant to the pharmaceutical industry
制药工厂相关cGMP专家
Strong knowledge of pharmaceutical, biotechnology or medical device related product operations including local and international quality regulations.
在制药、生物技术或医疗器械或相关产品领域的本地及国际质量法规相当熟悉
Demonstrate excellent verbal and written communication skills in English
英语口头沟通交流及书面表达流畅

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