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 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.)
