Senoir QA Auditor 北京

月薪： 1.5-2万/月

该公司所有职位
  • 5-7年经验
  • 招1人
  • 英语熟练
  • 02-08 发布
  • 五险一金
  • 餐饮补贴
  • 通讯补贴
  • 交通补贴

职位描述

RESPONSIBILITIES？ 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 experiencePHYSICAL 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： 生物工程/生物制药 药品生产/质量管理

联系方式

亦庄大族企业湾

公司信息

Q2 Solutions is a global clinical trials laboratory services organization formed as part of a joint venture transaction between QuintilesIMS and Quest Diagnostics. It comprises Quintiles’ former Global Central Laboratories, BioAnalytical/ADME and genomics businesses and Quest Diagnostics’ former clinical trials business. Q2 Solutions was born out of a shared commitment to quality, customer service and – above all – helping bring new treatments to patients. Q2 Solutions helps biopharma, medical device, and diagnostic customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is committed to providing our customers an innovative, progressive and responsive partner with the quality focus, global experience and deep medical expertise integral to drug, medical device, and diagnostic development. - See more at: http://www.q2labsolutions.com/about-us#sthash.TKFpb15K.dpuf

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