Audit Coordinator
India-Hyderabad-RemoteIndia, Remote Additional Locations: SAS Nagar (Mohali), India Job ID R0000031037 Category Quality Management
About this Role
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.
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