Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.
Post : Quality Associate, Quality Processes (GCP training coordinator)
Job Description
Leadership and Compliance :
• Provide support to Ergomed colleagues and functional teams in developing, managing, and implementing Controlled Procedures.
• Support GxP activities to ensure they are conducted in compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO.
• May provide guidance to Ergomend group staff over procedures and requirements related to GxP Quality Operations and Training as required.
Training and Development :
• Support GxP training activities across the Ergomed group, helping to ensure employees are adequately trained to meet global GxP requirements and client expectations, with support from the Learning and Development team.
• Support GxP training to ensure it is efficient and effective and that training activities are tracked to completion
• Partner with Learning and Development to assist in the development of effective training
Quality Management System Oversight :
• May assist in the triage and management of processes controlling access to Ergomed Group Quality Management System.
• Participate in efficiency projects to enhance the use and management of the Ergomed Group Quality Management System.
• Ensure access requests to Controlled Systems for employees and clients are correctly managed.
Business Continuity and Audit Support :
• Assist in Business Continuity activities across the Ergomed Group.
• Provide support to functional and Quality teams for audits and inspections by supplying reports or procedures from the Ergomed Group Quality Management System.
Metrics and Reporting :
• Aid the preparation and analysis of Quality Operations and Training related metrics, providing data and periodic reports to management as required.
• Assist in preparing any required CAPA or Deviation records resulting from issues in the Controlled Document, GxP Training or BCP process.
Team Leadership and Development
• Aid in fostering a collaborative, high performing quality culture across global teams and regions.
• Provide coaching and professional development opportunities to enhance team capability and succession planning.
Candidate Profile
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
Additional Information
Qualification : Pharmacy or BS/Master’s degree
Location : Pune, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Processes (GCP training coordinator)
End Date : 30th September 2026
Quality Associate : Apply Online
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