南京招聘

Job Purpose: The Auditor II will have experience and knowledge of appropriate GxP compliance and other applicable regulations and laws, PAREXEL procedures and appropriate PAREXEL processes, which allows the individual to plan and conduct internal and external audits independently, or with minimal supervision. Provide advice on regulatory compliance, with appropriate supervision.
Specialized Area:
Billable Audits & Client Relationships:
？ Ensure audits are performed to a high degree of client satisfaction and within the budgeted time
？ Ensure required audits are delivered in accordance with clients requirements and PAREXEL/Sponsor procedures as applicable
？ Ensure that systematic issues raised during billable audits are escalated to QA Lead
？ Develop and optimize new and existing processes to maintain and improve quality within the billable group.

Plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and PAREXEL/Sponsor procedures, independently or with minimal supervision. Perform and deliver high quality audits /audit reports within specified timelines / budgets, with oversight. Lead or participate in co-audits / observed audits with client representatives or other QA auditors. Travel internationally for audits as required.
Follow-up audits
Collect and review responses to audit observations and follow-up / escalate
inadequate or delayed responses as necessary to ensure timelines are met
and responses of satisfactory quality are obtained.
Support auditor training
Assist with the training of new / less experienced auditors by performing coaudits,
delivering training, and sharing knowledge and experience.
Maintain records / systems
Maintain required QA tools and ensure PAREXEL and QA systems are
regularly updated with accurate information for audits and other activities.
Provide consultancy
Provide advice on regulatory compliance to clients, PAREXEL Operations
and PAREXEL Quality. Support the development, maintenance, review and
improvement of PAREXEL procedures, systems and tools by providing
constructive ideas and suggestions.
Support the Sponsor Audit
and Inspection Team
Facilitate sponsor audits / regulatory inspections, as assigned
Fosters a good working relationship with internal and external clients
Promote compliance within
PAREXEL
Working knowledge and expertise of PAREXEL policies, procedures, and
guidelines, as well as applicable national and international regulations and
requirements; able to apply them as needed
Proactively recognize areas for process / procedural improvements,
providing input to management and taking the initiative, as appropriate

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。