DB-Quality Assurance Auditor/Manager社

面议

市辖区本科及以上3年及以上

发布时间：3天前

职位描述

工作职责：Primary Responsibilities and Accountabilities:
- Independently perform Quality activities including preparation, conductance, presentation, and timely reporting of outcomes, and evaluation of actions executions.
- Independently perform laboratory internal audits, facility inspections and study audits, recognize nonconformities, present observations and associated compliance risks to the teams, prepare audit reports.
- Manage quality issues to ensure all actions are appropriately and timely addressed.
- Lead discussions with team members and report any nonconformities and issues to management in a timely manner.
- Review internal SOPs, review study plan, data, and report to identify issues.
- Perform csv audit, provide compliance consultation related to csv related activities.
- Identify and coordinate to resolve potential risk areas through working with the team and management
- Provide training to business stakeholders as required.
- Perform tasks as assigned by management.
- Participate in authority inspections, CAP accreditations as needed.
任职资格：Qualifications:
- MS, BA degree in the quality related filed, or an equivalent education, training and experience.
- In-depth knowledge, maintain awareness and expertise in GLP/GCLP/GCP regulations and standards.
- 2 years’ experience in pharmaceutical industry with Quality Assurance background in a CAP/ISO15189/CNAS/GLP laboratory is preferred.
- Demonstrated knowledge in drug development and laboratory management.
- Good management, high discipline and proactive.
- Excellent communication skills and team work spirit.
- Confluent in reading, writing and speaking Engli**.

其他要求

招聘人数：1人
职能类别：

公司介绍

药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。
EstablishedinDecember2000,WuXiAppTecisaleadingglobalpharmaceutical,biopharmaceutical,andmedicaldeviceopen-accesscapabilityandtechnologyplatformwithoperationsinChinaandtheUnitedStates.Asaninnovation-drivenandcustomer-focusedcompany,WuXiAppTecprovidesabroadandintegratedportfolioofservicesthroughoutthedrugR&Dprocess.OurservicesaredesignedtohelpourworldwidecustomersshortenthediscoveryanddevelopmenttimeandlowerthecostofdrugandmedicaldeviceR&Dthroughcost-effectiveandefficientsolutions.