Quality Associate Quality Processes

PrimeVigilance; Pune District; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Ergomed is a specialist clinical research organization focusing on rare disease and oncology, delivering complex trials and ensuring data quality and patient safety. This role sits in the Quality Operations - Quality Process department and entails supporting GxP compliance, training initiatives, and audit readiness across the Ergomed Group.

The successful candidate will contribute to business continuity, tracking CAPA resolutions, and maintaining robust quality management practices across global

Qualifications

• Requires university degree in Biomedical/Natural/Health Sciences.
• Experience or suitable background in QA/Quality Operations preferred.
• Strong understanding of GxP, audits, and regulatory guidelines.

Responsibilities

• Support quality operations and training within the Ergomed group.
• Assist in GxP compliance activities and audits.
• Contribute to business continuity and CAPA processes.
• Prepare quality metrics and support management reporting.
• Provide coaching and development to team members.

Skills

GxP Compliance

Quality Operations

Training&Dvelopment

Team Leadership

Education

Biomedical/Natural/Health Sciences degree

Nursing/Pharmacy/BS or MSc in a scientific discipline

Job description

Job Description:

Company Description

Medicine moves forward here. So willyou.

Ergomed is a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,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.

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, dataqualityand the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported.

If you wantworkwith purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

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 toGxP Quality Operations and Training as required.

Training and Development:

• Support GxP training activities across the Ergomed group, helping to ensure employees areadequately trained to meet global GxP requirements and client expectations, with supportfrom the Learning and Development team.
• Support GxP training to ensure it is efficient and effective and that training activities aretracked 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 GroupQuality Management System.
• Participate in efficiency projects to enhance the use and management of the Ergomed GroupQuality Management System.
• Ensure access requests to Controlled Systems for employees and clients are correctlymanaged.

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 supplyingreports or procedures from the Ergomed Group Quality Management System.

Metrics and Reporting:

• Aid the preparation and analysis of Quality Operations and Training related metrics, providingdata and periodic reports to management as required.
• Assist in preparing any required CAPA or Deviation records resulting from issues in theControlled Document, GxP Training or BCP process.

Team Leadership and Development

• Aid in fostering a collaborative, high‑performing quality culture across global teams andregions.
• Provide coaching and professional development opportunities to enhance team capabilityand succession planning.

Qualifications

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

Department: Quality Operations - Quality Process

Requirements