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QualityAssuranceOfficer

面议

上海市

刷新时间:2022-08-23

职位描述

Position Description – Quality Assurance Officer

Overview:

To be in integral member of the Quality Assurance Team, establishing quality systems to ensure cGMP compliance for Shanghai Jinwei Biological Products (Jinwei BP) product manufacture and clinical trial activities. These relate to manufacture of plasmid and protein products.

GMP:
·Support/ maintain the Jinwei BP cGMP document archival system; including
oSupport document control in routing, reviewing, processing and archiving controlled documents such as SOP’s and technical reports.
oTrack and facilitate batch document review; ensure timely receipt, route to appropriate reviewers, ensure timely approval, archive once complete.
oFacilitate documentation of Quality investigations, ensure timely approval and archival once complete.
oMaintain supplier qualification files
oDocument and maintain file server access permissions approvals
oDraft QA based SOPs
·Maintain documentation for current lab cGMP training program by ensuring timely completion and archival of training records.
·Assist the Quality Assurance team in expanding the current training system and maintain it by ensuring timely completion and archival of training records.
·Perform QA document review, as appropriate to level of experience.
·Perform product batch review and release products for supply, as appropriate to level of experience
·Assist with validation activities including assisting in protocol preparation, managing internal review, approvals and archival.
·Review and archive Environmental Monitoring results.
·Assisting Quality Assurance Manager in reviewing quality system documentation for continuous improvement.
·Assist Quality Assurance manager for routine QA trending reports
·Involvement in staff training for GMP and internal audits
·Assure correct communication with external agents regarding product information, adverse events, market complaints.
·Assist in Risk Management processes, Out of Limits (OOL)/ Out of Specification (OOS), Deviations, CAPAs and Validation activities
·Additional QA responsibilities may be assigned to commensurate with candidate experience level.

Education and Experience:

·Minimum Bachelor of Science Degree in the physical or biological sciences. A degree in microbiology will be highly regarded.
·>3 years’ experience in a cGMP regulated industry, preferably in biological or pharmaceutical drug development.
·>1 year experience in Quality Assurance and familiarity with cGMP practices.
·Experience with local regulatory guidelines (MOH Decree No. 79) required. Familiarity with international regulatory guidelines, such as EMA and FDA (CFR21) regulations will be highly regarded.



Competencies:

·Excellent attention to detail
·Proven flexibility and adaptability
·Good writing and document preparation/management skills
·Advanced computer system skills
·Competent in project and time management
·Understanding and ability to interpret GMP guidelines
·Possess excellent interpersonal communication skills
·Must have the ability to communicate effectively with all levels of employees, including senior management
·Ability to work in both a team environment and independently
·Basic/professional proficiency in spoken and written English is mandatory

其他要求

  • 1人
  • QA总监/QA经理/QA主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
分公司总

企业信息

名称:
某生物科技有限公司
行业:
制药.生物
性质:
私营/民营企业
规模:
1-49人

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