Ergomed has announced an opening for a Quality Associate, Quality Processes (GCP Training Coordinator) in Pune, Maharashtra. This full-time opportunity is part of the Quality Operations – Quality Process department and offers remote working flexibility.

The Ergomed Quality Associate job is particularly relevant for candidates with educational backgrounds in Pharmacy, Nursing, Biomedical Sciences, Natural Sciences, Health Sciences, or other scientific disciplines.

The selected candidate will support GxP training, controlled procedures, Quality Management System (QMS) activities, audits, inspections, CAPA and deviation processes, and quality metrics across Ergomed’s global operations.

Ergomed Quality Associate Job Overview

About Ergomed

Ergomed is a specialist Clinical Research Organization (CRO) focused primarily on rare diseases and selected oncology indications. The organization works with biotechnology companies to support complex clinical trials and early-phase drug development.

This Quality Associate GCP Training Coordinator position supports Ergomed’s quality processes and global GxP compliance framework.

Key Responsibilities

As a Quality Associate at Ergomed, the selected candidate will support several Quality Operations activities, including:

GxP Compliance and Controlled Procedures

• Support Ergomed teams in developing, managing, and implementing controlled procedures.
• Support GxP activities according to applicable legislation, guidelines, and standards.
• Work with requirements associated with ICH, CIOMS and ISO standards.
• Provide procedural and GxP Quality Operations guidance when required.

GCP and GxP Training

• Support GxP training activities across Ergomed.
• Help ensure employees receive appropriate training to meet global GxP requirements.
• Track training activities through completion.
• Work with Learning and Development teams to support effective training programs.
• Help maintain efficient and compliant training processes.

Quality Management System

The Ergomed Quality Associate – GCP Training Coordinator will also support the company’s Quality Management System.

Responsibilities may include:

• Supporting access management for the Ergomed Group Quality Management System.
• Participating in QMS efficiency and improvement projects.
• Managing employee and client access requests to controlled systems.
• Supporting controlled-document processes.

Audit and Inspection Support

The candidate may assist Quality and functional teams during regulatory audits and inspections by:

• Providing required QMS reports.
• Retrieving controlled procedures.
• Supporting inspection-readiness activities.
• Assisting with Business Continuity activities.

CAPA, Deviations and Quality Metrics

Additional responsibilities include:

• Supporting preparation and analysis of Quality Operations metrics.
• Preparing periodic reports for management.
• Assisting with CAPA records.
• Supporting Deviation records associated with controlled documents, GxP training or business continuity processes.
• Helping promote a collaborative quality culture across global teams.

Qualification Requirements

Ergomed states that candidates should have a university degree in:

• Pharmacy
• Nursing
• Biomedical Sciences
• Natural Sciences
• Health Sciences
• Bachelor’s or Master’s degree in a scientific discipline

Candidates with suitable relevant experience may also be considered.

Therefore, B.Pharm, M.Pharm, Pharm.D and other relevant life-science or healthcare graduates may be suitable where their education and experience align with the employer’s requirements.

Skills Relevant to the Ergomed Quality Associate Role

Candidates interested in this GCP Quality Associate job in Pune should ideally understand or develop knowledge of:

• Good Clinical Practice (GCP)
• GxP principles
• Quality Management Systems (QMS)
• Controlled documents and SOPs
• ICH guidelines
• CAPA and deviation management
• Training coordination
• Audit and inspection support
• Quality metrics and reporting
• Document control
• Business Continuity Processes
• Pharmaceutical and clinical research quality systems

Is This a Pharmacovigilance Job?

This position is not primarily a Pharmacovigilance case-processing role.

It belongs to Quality Operations and focuses primarily on GxP/GCP training, QMS processes, controlled documentation, quality compliance, CAPA, deviations, audits, inspections, and training management.

Candidates with pharmaceutical quality, clinical research, GCP, GxP, QMS or compliance backgrounds may therefore find this role particularly relevant.

Benefits of This Opportunity

Based on the official job description, candidates can expect:

• Opportunity to work with a global specialist CRO.
• Exposure to international GxP quality operations.
• Experience with GCP training and Quality Management Systems.
• Involvement in audits and regulatory inspection support.
• Exposure to CAPA and deviation processes.
• Collaboration with international functional and quality teams.
• Professional development opportunities.
• Remote working flexibility associated with the Pune position.
• Exposure to rare disease and oncology clinical research operations.

Expected Salary

Ergomed has not disclosed the salary for this position in the provided job advertisement.

For structured-data purposes, an estimated market range for a Quality Associate-level life-sciences role in India may be approximately ₹5,00,000 to ₹9,00,000 per year, depending on relevant experience, skills, previous CRO exposure and the final compensation offered by the employer.

Note: This is an estimated range and not an officially disclosed Ergomed salary.

How to Apply

Application Link