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Quality Assurance Opportunities at Parexel

By being hired into one of our Quality Assurance jobs at Parexel International, you’ll be a key member of the Parexel International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at Parexel International may be waiting for you!

Quality Assurance Auditor II

Job ID 51761BR Shanghai, Shanghai Municipality, China
Specialized Area:
Billable Audits & Client Relationships:
• Ensure audits are performed to a high degree of client satisfaction and within the budgeted time
• Ensure required audits are delivered in accordance with clients requirements and PAREXEL/Sponsor procedures as applicable
• Ensure that systematic issues raised during billable audits are escalated to QA Lead
• Develop and optimize new and existing processes to maintain and improve quality within the billable group.

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.
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 PAREXEL and QA systems are regularly updated with accurate information for audits and other activities.
Provide consultancy
• Provide advice on regulatory compliance to clients, PAREXEL Operations and PAREXEL Quality. Support the development, maintenance, review and improvement of PAREXEL procedures, systems and tools by providing constructive ideas and suggestions.
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 PAREXEL
• 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
• Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate

Perform and Report audits
• Plan, schedule, conduct and report a range of GxP audits in accordance with client requirements and PAREXEL/Sponsor procedures, independently or with minimal supervision. Perform and deliver high quality audits /audit reports within specified timelines / budgets, with oversight. Lead or participate in co-audits / observed audits with client representatives or other QA auditors. Travel internationally for audits as required.

Skills:
• Ability to interact professionally at multiple levels within a client oriented organization
• Excellent organizational skills
• Excellent written and verbal communication skills
• Excellent analytical skills
• Ability to manage multiple and varied tasks, and prioritize workload
• Willingness to work with multiple supervisors in a matrix environment and to value the importance of teamwork
• Ability to work professionally with highly confidential information
• Experience with Microsoft based applications, and ability to learn internal computer systems
• 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
• A team player with a positive attitude
• Ability to work consistently in a fast-paced environment
• Working knowledge of regulations
• Accurate and detail oriented
• Ability to work independently
• Ability to understand, apply, and explain concepts
• Ability to draw conclusions, considering the ‘big picture’/ combining details to understand process(es) / issue(s)
• Competent with strong problem solving and negotiation

Qualifications

Knowledge and Experience:
• Relevant experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including relevant experience of applicable GxP auditing
• Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials
• Experience with using computer systems and software, including Microsoft Office
• Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business
• Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.

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

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