南京招聘

Key Accountabilities

• Implement the standard quality interventions for assigned projects, verifying compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
• Review key project documentation and provide feedback to the project team.
• Actively participate in key internal project team meetings and facilitate quality discussions during these meetings, as appropriate.
• Lead quality-focused meetings and/or discussions, as appropriate.
• Provide quality consultation support to project teams.
• Provide CAPA support to project teams including classification of issues, consultation on appropriateness of corrective and preventive actions and tracking of CAPAs through resolution.
• Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections. Review and provide feedback on project related audit/inspection responses generated by project team members prior to finalization. Represent Operations Quality Management in audits and inspections as required.
• Oversee the collection and reporting of project quality metrics.

Risk-Based Quality Interventions

• Identify and evaluate potential risks, in collaboration with project team management and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures.
• Implement additional quality interventions in areas of risk.

Other Accountabilities

• Identify process improvement opportunities and champion their implementation as assigned.
• Participate in SOP and process development as assigned.
• Maintain an understanding of PAREXEL standard operating procedures that are relevant to the assigned project(s) and of relevant regulations and guidelines.
• Perform other quality related tasks as assigned.

Skills

• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
• IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
• Ability to travel as needed

Education

• University degree (preferably in a relevant area such as biological science, pharmacy, other health related discipline or technology), equivalent qualification or relevant experience.

Language Skills

• English proficiency (written and oral English)

Minimum Work Experience

• Relevant experience (e.g., in the pharmaceutical or CRO industry or in the Technology field).

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。