Audit Coordinator

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

General Administrative Duties

• Organize meetings and business trips, write meeting minutes, submit travel expenses, as required

• Download and distribute regular reports, listings etc. utilizing appropriate technologies and systems

• Provide support in the generation and analysis of reports and questionnaires, as required

• Drive compilation of data and requested information for Management’s business needs

• Assist with client deliverables, e.g. audit reports, metrics

• Prepare/update/distribute departmental organization charts

• Oversee and maintain relevant departmental Sharepoint folders/SharePoint access, as required

• Support stakeholder review assignments for SOP reviews

• Extract awarded signed audits report monthly in Planisware

• Assist in Sponsor Audit and Regulatory Inspection (SAI), as required (e.g. extranet access, PMEX set-up, etc.)

• Assist GxP audits with sample selection, coordination and follow up activities, as needed

• Gather necessary documents such as CVs, JDs, and training packages to support an SAI

• Contribute to Lessons Learned to ensure continuous quality improvement

• Schedule QA Global calls

• Utilize AI to support admin and QA personnel, e.g. potential efficiencies with RFI/RFP, project selection

• Maintain applicable admin related MI/GI linked with QA SOPs

Metrics and Trending Support

• Collect, analyze and interpret data from various sources

• Generate reports and visualizations to effectively communicate trends, patterns and key performance indicators to stakeholders

• Identify trends in quality metrics to highlight potential areas for improvement

Additional Accountability

• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel’s international SOPs and compliance with GxP.  

• Promote compliance within the company and represent QA

• Develop and maintain network contacts with other Quality Assurance professionals

• Work to support department efficiency through sharing knowledge/tasks

• Support Activities for QA team and manage special projects as assigned (e.g. billable deliverable activities)

• Develop guidance documentation, processes, and tools for administrative tasks, as assigned

• Assist with QA data entries, as required

• Build, develop, and maintain good working relationships with internal and external customer groups.

• Work well in team environment.

• Perform other quality related tasks or duties as assigned

• Travel on assignments as required. Travel time could be up to 10%

Skills:

• Sound organizational skills, ability to prioritize workload and manage multiple, potentially conflicting deadlines with attention to detail and within agreed timelines

• Comprehensive knowledge of relevant Microsoft office software: Windows, Word, Excel, PowerPoint, Outlook

• Excellent interpersonal, verbal and written communication skills

• Ability to take initiative

• Shows commitment to high quality work

• Self-motivated with willingness to accept responsibilities and challenges

• Flexible ‘can do’ attitude to problem solving and with respect to work assignments and new learnings

• Experience with and ability to adhere to strict confidentiality requirements

• Ability to remain calm under pressure

• Willingness to work in a matrix environment and values the importance of teamwork

• Global mindset; ability to work in a decentralized/remote team environment

Additional Skills:

• Excellent Microsoft office skills

• Excellent Microsoft Excel skills, including knowledge of formulas, pivots, look up tables and chart generation preferred.

Knowledge and Experience:

• Preferred 1- 2 years of experience in Quality Assurance, relevant Quality Management and/or clinical trial support or administrative work

• Knowledge of GxP, industry standards, applicable regional regulations

• A team player with a positive attitude and detail oriented

Education:

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

• Strong command of written and spoken English language, local language proficiency as required.