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Quality Assurance Auditor II

职位编号 R0000006521 工作地点 沈阳窝堡, 辽宁 职位描述

Accountability/Supporting Activities

Perform and Report audits

  • Independently plan, schedule, perform and report a range of GxP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, safety/pharmacovigilance (PV) audits.
  • 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. Travel time could be up to approx. 60%

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 internal and billable audit programs

  • Work with client QA and Parexel Operations to plan and manage a global program of audits.
  • Resolve program related issues in a constructive and pro-active way.
  • Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time.
  • Review audit reports, responses and other program deliverable to ensure consistent high quality.

Billable Audits/Audit programs & Client Relationships (where applicable)

  • Act as QA Lead on audits program(s) as assigned by Line Management.
  • Ensure audits programs are managed to a high degree of client satisfaction.
  • Arrange meetings with client and other key stakeholders as required.
  • Ensure required audits are delivered in accordance with clients’ requirements and Parexel/ client procedures as applicable.
  • Ensure that systematic issues raised during billable audits are escalated and addressed.
  • Maintain relationships with clients.
  • Support client QA needs and identify areas where billable services may be offered.
  • Develop and optimize new and existing processes to maintain and improve quality within the billable group.

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.

Understand Parexel policies, procedures, and guidelines

  • Maintain compliance with training curriculum.
  • Review Parexel SOPs as assigned to ensure GxP compliance of processes.

Process improvements

  • Support QA Management to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).

Provide local, regional and global consultancy

  • Provide advice on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.
  • Support the development, maintenance, review and improvement of Parexel procedures, systems and tools by providing constructive ideas and suggestions.
  • Provide input on QA planning and strategy as requested.

Support Client Audits and Regulatory Inspections

  • Facilitate client audits / regulatory inspections, as assigned.
  • Foster 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.

Build and maintain relationships

  • Build, and maintain good working relationships with internal and external customer groups
  • Work well in team environment.

Perform other quality related task or projects as assigned

  • Perform other quality related tasks or initiatives as assigned.


  • Ability to rapidly learn, understand and apply applicable Parexel and client procedures
  • Ability to learn and use Parexel and client computer systems
  • Client focused approach to work
  • Ability to develop good working relationships with a culturally diverse group of Parexel 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 other 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.

Knowledge and Experience:

  • Preferred minimum of 2 years’ experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area such as technology, third party supplier management, including sound experience of applicable GxP auditing
  • Preferred minimum of two year experience
  • Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
  • 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.


  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
  • Master’s degree in a science, technology or industry related discipline, preferred.