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Quality Assurance Auditor I

Parexel International Corporation

Shenyang Wobu, Liaoning, China

Accountability Supporting Activities

Perform and Report audits • Independently plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and Sponsor procedures.

• Perform and deliver high quality audits /audit reports within specified timelines / budgets, with limited oversight. Lead or participate in co-audits / observed audits with client representatives or other QA auditors. Travel internationally for audits as required.

• Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports

Follow-up audits • Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained.

Lead audit programs • Work with client QA and Operations to plan and manage a program of audits. Resolve program related issues in a constructive and pro-active way. Ensure required audits are performed and reported in accordance with the client and QA requirements, on time and on budget. Review audit reports, responses and other program deliverable to ensure consistent high quality. Arrange meetings with client and other key stakeholders as required. Ensure customer satisfaction and program profitability.

Support auditor training • Assist with the training of new / less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience.

Maintain records / systems • Maintain required QA tools and ensure and QA systems are regularly updated with accurate information for audits and other activities.

Provide consultancy • Provide advice on regulatory compliance to clients, Operations and Quality. Support the development, maintenance, review and improvement of procedures, systems and tools by providing constructive ideas and suggestions. Provide input on QA planning and strategy as requested.

Support the Sponsor Audit and Inspection Team • Facilitate sponsor audits / regulatory inspections, as assigned

• Fosters a good working relationship with internal and external clients

Promote compliance within • Working knowledge and expertise of policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed

• Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate

Skills:

• Ability to rapidly learn, understand and apply applicable and Sponsor procedures

• Ability to learn and use and client computer systems

• Client focused approach to work

• Ability to develop good working relationships with a culturally diverse group and client personnel

• Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork

• Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions

• Ability to mentor / train auditors and others personnel

• Excellent organizational, analytical, problem solving and negotiation skills

• Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions

• Ability to work independently and consistently in a fast-paced environment

• Accurate and detail oriented

• Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm

• A flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events

• Ability to diplomatically address sensitive issues confidentially and professionally

• Ability to work professionally with highly confidential information

• Team leadership abilities and positive attitude

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

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience

Job posted: 2020-09-23

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