Quality Assurance Coordinator

Accountabilities:

• • Coordinate pre-audit, audit, inspection, and post-inspection activities under the direction of Quality Assurance and Regulatory Compliance leadership.
  • Schedule audits and regulatory inspections while managing associated logistics, timelines, documentation, and stakeholder communications.
  • Partner with audit and inspection hosts to organize required documentation, supporting evidence, schedules, and subject matter expert availability.
  • Work with management and cross-functional teams to ensure projects, processes, and documentation remain audit and inspection ready.
  • Review documentation for completeness, accuracy, and consistency, identifying gaps, risks, or missing information that may affect readiness.
  • Assist with collecting, tracking, organizing, and coordinating responses to preliminary audit findings and inspection observations.
  • Maintain audit and inspection archives, libraries, and quality documentation within designated repositories and systems.
  • Coordinate project documentation, schedules, data requests, action items, and stakeholder activities associated with quality and regulatory compliance programs.
  • Support the maintenance of quality systems documentation and contribute to the accuracy and integrity of compliance records.
  • Assist with special projects, process improvement initiatives, and other quality-related activities as required.
  • Support global audits and inspections by coordinating with stakeholders across different regions and time zones.
  • Promote a culture of quality, compliance, continuous improvement, and operational excellence across assigned activities.

  Requirements:

  • Associate’s or Bachelor’s degree, or an equivalent combination of education, certifications, and relevant professional experience.
  • 1–3 years of experience working in a GxP-regulated environment or another highly regulated industry.
  • Experience coordinating complex schedules, meetings, documentation, projects, or operational activities with multiple stakeholders.
  • Exposure to audits, regulatory inspections, quality systems, or compliance programs is preferred.
  • Familiarity with quality and regulatory frameworks such as ICH GCP, 21 CFR Part 11, 21 CFR 820, ISO 9001, ISO 13485, ISO 27001, or related standards is an advantage.
  • Strong proficiency with Microsoft Office applications, particularly Outlook, Word, Excel, PowerPoint, and Microsoft Teams.
  • Excellent organizational and project coordination skills, with the ability to manage multiple priorities, deadlines, and stakeholders simultaneously.
  • Strong written and verbal English communication skills, with the ability to communicate clearly with global teams.
  • Excellent attention to detail, analytical ability, and commitment to documentation accuracy.
  • Experience with Quality Management Systems such as TrackWise or Veeva is an added advantage.
  • Ability to work independently while collaborating effectively with geographically distributed teams.
  • Willingness and ability to work primarily during US business hours, approximately 5:00 PM to 2:00 AM IST.
  • Flexibility to periodically work non-standard hours to support global audits, inspections, and compliance activities.
  • Professional, dependable, and quality-focused approach to working in deadline-driven environments.

  Benefits:

  • Competitive compensation and incentive opportunities.
  • Provident fund and medical insurance.
  • Remote work flexibility and access to modern office facilities.
  • Employee engagement programs and local events.
  • Opportunities for professional development, learning, and career growth within a global organization.
  • Exposure to international quality, regulatory, audit, and inspection activities.
  • Opportunity to collaborate with global teams and gain experience in highly regulated clinical research and healthcare technology environments.
  • Meaningful work supporting quality and compliance activities that contribute to the advancement of clinical research and healthcare technologies.