Quality Assurance Auditor 上海

月薪： 1.5-2万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： 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 assignedJob 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 teamKnowledge 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 auditingEducation:? Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.) 职能类别： 其他 临床研究员

联系方式

上海市浦东新区银城中路488号太平金融大厦20层

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

上海相关职位
猎才二维码