Senior Clinical Auditor-Pharma/CRO company
摹根麦肯立人才服务（上海）有限公司
- 公司规模：少于50人
- 公司行业：专业服务(咨询、人力资源、财会) 中介服务
职位信息
- 发布日期：2012-11-09
- 工作地点：北京
- 招聘人数：若干
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床研究员 临床数据分析员
职位描述
Senior Auditor
The Senior Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, PHARMA COMPANY procedures and appropriate PHARMA COMPANY processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors.
? Working knowledge and expertise of PHARMA COMPANY 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 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 working knowledge of project /audit status
? Maintain and / or develop records / documents related to assigned areas
? Mentor and assist with training of less experienced auditors
? Facilitate sponsor audits / regulatory inspections, as assigned
? Travel on assignment
? Other duties as assigned
? Use in-depth understanding of appropriate GCP compliance and other applicable regulations and laws to provide guidance to PHARMA COMPANY and our clients regarding compliance issues
Experience:
? Bachelor's degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.)
? Ability to develop relationships with a culturally diverse group of key stakeholders within PHARMA COMPANY 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
? Motivated to work and perform consistently in a fast-paced environment
? 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
? 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 RRC members (QA)
? Promote team work within the RRC team (QA)
? Excellent language skills in English, second mandarin language
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
The Senior Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, PHARMA COMPANY procedures and appropriate PHARMA COMPANY processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors.
? Working knowledge and expertise of PHARMA COMPANY 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 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 working knowledge of project /audit status
? Maintain and / or develop records / documents related to assigned areas
? Mentor and assist with training of less experienced auditors
? Facilitate sponsor audits / regulatory inspections, as assigned
? Travel on assignment
? Other duties as assigned
? Use in-depth understanding of appropriate GCP compliance and other applicable regulations and laws to provide guidance to PHARMA COMPANY and our clients regarding compliance issues
Experience:
? Bachelor's degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.)
? Ability to develop relationships with a culturally diverse group of key stakeholders within PHARMA COMPANY 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
? Motivated to work and perform consistently in a fast-paced environment
? 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
? 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 RRC members (QA)
? Promote team work within the RRC team (QA)
? Excellent language skills in English, second mandarin language
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
公司介绍
摹根麦肯立于1995年成立于英国，为英国各知名金融机构提供高标准的求职者，是众多投资银行和金融服务领域大型企业的首选合作伙。2005年，摹根麦肯立由Imprint Plc公司并购。公司合并后，如虎添翼，业务全面发展，是欧洲发展最快的人才服务公司。2008年，摹根麦肯立公司被Premier Group收购。目前摹根麦肯立在英国、欧洲大陆、中东及亚太地区拥有21个办公室，成为全球人才服务领域的领导者。