Ergomed is hiring for the position of Quality Associate, Quality Processes in Pune, Maharashtra. This full-time opportunity is part of the Quality Operations – Quality Process department and supports GxP quality processes, controlled procedures, training, Quality Management Systems (QMS), audits, CAPA, deviations and quality metrics.

Candidates with a university degree in Biomedical Sciences, Natural Sciences or Health Sciences, including Pharmacy and Nursing, or a BS/Master’s degree in a scientific discipline are eligible as specified in the job description. Suitable experience may also be considered.

Ergomed Quality Associate Job Overview

About Ergomed

Ergomed is a specialist clinical research organization (CRO) focused on rare diseases and select oncology indications. The organization partners with small and midsize biotechnology companies, supporting complex clinical trials and early-phase drug development.

The company operates internationally across North America, South America, Europe, Asia and Australia and emphasizes collaboration, flexibility, professional development and work-life balance.

Key Responsibilities

As a Quality Associate, Quality Processes at Ergomed, responsibilities include:

• Support the development, management and implementation of Controlled Procedures.
• Support GxP activities to ensure compliance with applicable legislation, guidelines and standards, including ICH, CIOMS and ISO.
• Provide support and guidance related to GxP Quality Operations and Training requirements.
• Support GxP training activities across the Ergomed group.
• Help ensure employees receive appropriate training to meet global GxP requirements and client expectations.
• Track GxP training activities through completion.
• Partner with Learning and Development to support effective training development.
• Assist with processes controlling access to the Ergomed Group Quality Management System.
• Participate in projects aimed at improving the efficiency and management of the QMS.
• Manage employee and client access requests for Controlled Systems.
• Support Business Continuity activities.
• Assist Quality and functional teams during audits and inspections by providing relevant reports and controlled procedures.
• Support preparation and analysis of Quality Operations and Training metrics.
• Prepare data and periodic quality reports for management when required.
• Assist with CAPA and Deviation records arising from Controlled Document, GxP Training or Business Continuity processes.
• Contribute to a collaborative and high-performing quality culture across global teams.
• Support coaching and professional development activities.

Qualifications

Ergomed specifies a university degree in Biomedical Sciences, Natural Sciences or Health Sciences as required. Relevant qualifications mentioned in the job description include:

• Nursing
• Pharmacy
• Biomedical Sciences
• Natural Sciences
• Health Sciences
• BS degree in a scientific discipline
• Master’s degree in a scientific discipline
• Suitable experience may also be considered

Key Skills for the Quality Associate Role

Candidates applying for the Ergomed Quality Associate position may benefit from knowledge or understanding of:

• GxP Quality Operations
• Quality Management Systems (QMS)
• Controlled Documents and Procedures
• GxP Training
• ICH guidelines
• CIOMS
• ISO standards
• CAPA
• Deviation Management
• Audit and Inspection Support
• Business Continuity Processes
• Quality Metrics and Reporting
• Training Management
• Cross-functional collaboration

Benefits and Work Environment

The job description highlights Ergomed’s international and collaborative work environment. The company emphasizes:

• Professional growth and career development
• International collaboration
• Flexible working culture
• Early ownership and responsibility
• Work-life balance
• Opportunity to contribute to rare disease and oncology clinical research

Specific compensation or employee benefit amounts were not disclosed in the provided job posting.

How to Apply

Application Link