Senior QA Auditor 北京

月薪： 2-2.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 补充医疗保险
  • 五险一金
  • 年终奖金
  • 定期体检
  • 餐饮补贴

职位描述

职位描述： Location: Beijing (preferred) or ShanghaiRESPONSIBILITIES● Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions. ● Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers. ● Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. ● Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans. ● Prepare and review and approve corrective action plans ● Present educational programs and provide guidance to operational staff on compliance procedures. ● Conduct quality assurance consultancy activities and projects for clients within budget and established timelines. ● Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements. ● Host customer audits, ● Assist in hosting mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed. ● Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections. ● May perform GLP Archivist duties where needed. ● Assist in training of new Quality Assurance staff. All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIES● Knowledge of word-processing, spreadsheet, and database applications. ● Extensive knowledge of pharmaceutical research and development processes and regulatory environments. ● Knowledge of quality assurance processes and procedures. ● Strong interpersonal skills. ● Excellent problem solving, risk analysis and negotiation skills. ● Strong training capabilities. ● Effective organization, communication, and team orientation skills. ● Ability to initiate assigned tasks and to work independently. ● Ability to manage multiple projects. ● Ability to establish and maintain effective working relationships with coworkers, managers and clientsMINIMUM REQUIRED EDUCATION AND EXPERIENCE ● Bachelor’s/primary degree ● 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS ● Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time ● Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech ● Travel required, may include international travel. 职能类别： 药品注册 生物工程/生物制药 关键字： QA, quality, QC, GCP

联系方式

北京东城区王府井大街

公司信息

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you.

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