Quality Associate, Quality Processes – GCP Training Coordinator

ERGOMED

Quality Associate coordinating GCP training, controlled procedures, and quality systems for Ergomed’s rare disease and oncology clinical research trials.

Posted 8/20/2026full-timeRemote • 🇮🇳 IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP Quality Operations and Training, ensuring compliance with applicable legislation and standards while fostering a collaborative quality culture. Proficient in managing Quality Management System access and preparing quality metrics and CAPA records.

Highest-signal resume keywords

GxP Quality OperationsQuality Management System AccessTraining Metrics AnalysisCAPA Records PreparationCompliance with ICH, CIOMS, and ISO

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GxP ComplianceQuality Metrics AnalysisCAPA ManagementTraining DevelopmentQuality Management System Management

Soft Skills

CoachingCollaborationProfessional Development Support

Industry Keywords

Biomedical SciencesNatural SciencesHealth SciencesAuditsInspections

About the role

Key responsibilities & impact

Support colleagues and functional teams in developing, managing, and implementing Controlled Procedures
Support GxP activities to ensure compliance with applicable legislation, guidelines, and standards
Provide guidance on GxP Quality Operations and Training procedures and requirements
Support GxP training activities across the Ergomed group
Help ensure training is efficient, effective, and tracked to completion
Partner with Learning and Development to assist in developing effective training
Assist in triage and management of access to the Quality Management System
Participate in projects improving Quality Management System use and management
Manage access requests to Controlled Systems for employees and clients
Assist with Business Continuity activities across the Ergomed Group
Support audits and inspections by supplying reports or procedures
Prepare and analyze Quality Operations and Training metrics and periodic management reports
Assist with CAPA or Deviation records resulting from process issues
Foster a collaborative, high-performing quality culture across global teams and regions
Provide coaching and professional development support for team capability and succession planning

Requirements

What you’ll need

University degree in Biomedical sciences, Natural sciences or Health Sciences is required
Nursing, Pharmacy, or BS/Master’s degree in a scientific discipline, or suitable experience
Knowledge of applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO
Experience or capability related to GxP Quality Operations and Training
Ability to support GxP training activities and track completion
Ability to assist with Quality Management System access processes
Ability to support business continuity, audits, and inspections
Ability to prepare and analyze quality and training metrics
Ability to prepare CAPA or Deviation records
Ability to foster quality culture, coach, and support professional development

Benefits

Comp & perks

Remote work permitted
Work-life balance
Collaborative, international team environment
Career growth opportunities
Early ownership and professional development opportunities
Coaching and professional development opportunities