Job Title: Audit Coordinator
Location: India (Hyderabad - Remote, SAS Nagar (Mohali), India)
Job ID: R0000031037
Category: Quality Management
Role Overview:
The Audit Coordinator will be responsible for supporting audit activities, administrative duties, and metrics tracking within the Quality Assurance (QA) department. This includes organizing meetings, preparing reports, maintaining departmental records, and supporting GxP audit-related activities. The Audit Coordinator will also assist in driving quality improvement initiatives and play a crucial role in maintaining compliance with relevant GxP requirements.
Key Responsibilities:
General Administrative Duties:
Organize meetings, business trips, and submit travel expenses as required.
Download and distribute regular reports and listings using appropriate technologies and systems.
Assist with generating and analyzing reports and questionnaires.
Drive the compilation of data and requested information for management’s business needs.
Support in the preparation of client deliverables, including audit reports and metrics.
Maintain and update departmental organization charts.
Oversee and maintain relevant departmental SharePoint folders and access.
Assist with Stakeholder Review Assignments for SOP reviews.
Assist with Sponsor Audit and Regulatory Inspection (SAI), such as extranet access and PMEX set-up.
Assist with GxP audits, including sample selection, coordination, and follow-up activities.
Gather necessary documents (e.g., CVs, JDs, training packages) for an SAI.
Contribute to "Lessons Learned" initiatives for continuous quality improvement.
Schedule global QA calls and support administrative tasks using AI to optimize efficiencies.
Metrics and Trending Support:
Collect, analyze, and interpret data from various sources.
Generate reports and visualizations to effectively communicate trends, patterns, and KPIs to stakeholders.
Identify trends in quality metrics and highlight areas for improvement.
Additional Responsibilities:
Maintain knowledge of GxP requirements and their impact on Parexel’s SOPs and compliance.
Promote compliance within the company and represent the QA function.
Build a network with other Quality Assurance professionals.
Support QA team efficiency through knowledge sharing and managing special projects.
Assist with QA data entries and develop guidance documentation for administrative tasks.
Work collaboratively with internal and external customer groups.
Travel on assignments, up to 10% as required.
Skills and Competencies:
Strong organizational skills, ability to manage conflicting deadlines with attention to detail.
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Excellent interpersonal, verbal, and written communication skills.
Initiative-driven with a commitment to high-quality work.
Self-motivated and capable of handling responsibilities and challenges.
Ability to work effectively in a matrix environment and value teamwork.
Global mindset with the ability to work in a decentralized/remote team.
Strong problem-solving skills and flexibility in handling work assignments.
Adherence to confidentiality requirements and ability to remain calm under pressure.
Additional Skills:
Advanced Microsoft Excel skills (formulas, pivots, look-up tables, and chart generation).
Experience with GxP, industry standards, and regional regulations is an advantage.
Knowledge and Experience:
Preferred 1-2 years of experience in Quality Assurance, Quality Management, or clinical trial support.
Understanding of GxP and applicable regulatory requirements.
Team player with a positive attitude and detail-oriented.
Education:
A degree in a relevant field (e.g., technology, biological science, pharmacy, or other health-related disciplines) or equivalent qualification.
Clinical research experience is a plus.
Strong command of written and spoken English; local language proficiency as required.
This role offers the opportunity to play a vital part in ensuring quality compliance and efficient audit coordination within the organization. If you have an interest in Quality Assurance and administrative functions, this position could be a great fit.
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