The role involves managing and maintaining the Quality Management System (QMS), reviewing and updating SOPs, handling CAPA, deviations, change controls, complaints, non-conformances, conducting internal and supporting external audits, ensuring compliance with applicable regulatory and quality standards, and monitoring quality processes across clinical supply chain operations. The candidate will work closely with cross-functional teams to identify quality risks, implement corrective and preventive actions, maintain accurate documentation, and ensure continuous improvement of quality processes.

Qualifications

- Manage and maintain the Quality Management System (QMS).
- Prepare, review, update, and implement SOPs and quality documents.
- Handle CAPA, deviations, change controls, complaints, and non-conformances.
- Conduct and support internal and external audits.
- Investigate quality issues and identify root causes.
- Ensure proper documentation, record maintenance, and quality compliance.




- Monitor quality activities related to clinical supply chain operations.
- Coordinate with internal teams and stakeholders to resolve quality-related issues.
- Support regulatory and client audits and ensure timely closure of observations.
- Identify quality risks and support implementation of appropriate mitigation measures.
- Drive continuous improvement of quality processes and systems.
- Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
- 2–3+ years of relevant experience in Quality Assurance, preferably within clinical supply chain, pharmaceutical, medical device, or healthcare environments.
- Hands-on experience with QMS, CAPA, Deviations, Change Control, SOPs, and Audits.
- Valuable understanding of applicable GxP/quality and regulatory requirements.
- Strong documentation, analytical, communication, and stakeholder-management skills.

📌 Quality Assurance Associate (New Delhi)
🏢 Intrinseque Health
📍 New Delhi