Quality Assurance Coordinator

Audit & Inspection Readiness: Coordinate and support end-to-end pre-audit, audit, inspection, and post-inspection operations under the guidance of QA and Regulatory Compliance leadership.

Logistics & Schedule Management: Schedule quality audits and regulatory inspections; manage stakeholder communications, expert availability, and meeting logistics across global time zones (US shift: 5:00 PM – 2:00 AM IST).

Document Review & Gap Analysis: Partner with audit hosts to organize required evidence and study documentation; review records for completeness and identify gaps, compliance risks, or missing documentation.

CAPA & Finding Tracking: Assist with tracking, obtaining, and organizing structured responses to preliminary audit findings and regulatory inspection observations.

Quality Repository & Archive Maintenance: Maintain audit libraries, document archives, and related quality management systems documentation in designated repositories.

Strong understanding of GxP compliance regulations, ICH-GCP guidelines, 21 CFR Part 11, 21 CFR 820, and relevant ISO standards (ISO 9001, ISO 13485, ISO 27001).

High accuracy in documentation control, project coordination, and multi-stakeholder scheduling.

Comprehensive medical insurance and provident fund benefits.

Remote work flexibility with dedicated shift allowances for US time zone coverage and global development opportunities within Thermo Fisher Scientific.