Audit Coordinator

India-Hyderabad-Remote
India, 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.

LI-REMOTE