南京招聘

Job Purpose: The Auditor will have an in-depth understanding 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 and to be able to mentor less experienced auditors. Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically. In liaison with QA Management and staff, provide direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance.

Key Accountabilities:
? Facilitate sponsor audits / regulatory inspections, as assigned
? Fosters a good working relationship with internal and external clients
? 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
? Promotion of compliance within the company
? Plan and conduct audits, including global and complex assignments, delivering a written report
? Proactively provide input to management on audit plans / strategy
? Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate
? Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
? Maintain QA oversight and deliver QA consultancy for assigned countries/departments
? Maintain and / or develop records / documents related to assigned areas
? Mentor and assist with training of less experienced auditors
? Travel on assignment
? Other duties as assigned


Job Qualifications :
 
Skills:
? Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
? Excellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessions
? Excellent analytical skills
? Ability to manage multiple and varied tasks, and prioritize workload
? Experience with Microsoft based applications, and ability to learn internal computer systems
? Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
? Accurate and detail oriented
? Excellent organizational skills
? Motivated to work and perform consistently in a fast-paced environment
? Ability to execute strategy and plans
? High degree of flexibility and ability to adjust to changing priorities and unforeseen events
? Excellent time management skills and the ability to follow-up on multiple tasks and projects
? Ability to diplomatically address sensitive issues confidentially and professionally
? Team leadership abilities and positive attitude
? Excellent knowledge of, and working experience with, regulations
? Excellent problem solving and negotiation skills
? Ability to work professionally with highly confidential information
? Ability to work independently and consistently in a fast-paced environment
? Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
? Ability to train new and existing less experienced QA members
? Promote team work within the QA team

Knowledge and Experience:
? Substantial experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including sound experience of applicable GxP auditing

Education:
? Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.)

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。