The role involves managing Quality Assurance and Regulatory Affairs activities within a clinical and pharmaceutical environment. The candidate will be responsible for maintaining quality management systems, ensuring compliance with applicable regulatory requirements, managing documentation, and supporting audits and quality processes. The role also includes regulatory documentation, SOP management, CAPA, deviation handling, and coordination with internal teams to maintain quality standards and regulatory compliance.

Qualification:

• Maintain and update the Quality Management System (QMS).
• Handle CAPA, deviation management, non-conformances, and SOP documentation.
• Ensure compliance with applicable regulatory guidelines and quality standards.
• Support internal and external audits and maintain quality records.
• Assist with regulatory documentation, submissions,



and compliance tracking.
• Coordinate with internal teams to resolve quality and regulatory issues.
• Ensure documentation meets applicable ISO and regulatory requirements.
• Requirements
• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
• 2–3 years of relevant experience in QA/RA within a pharmaceutical, clinical, or healthcare-related environment.
• Practical experience with QMS, CAPA, deviations, and SOPs.
• Knowledge of applicable standards such as ISO 13485, ISO 9001, or relevant regulatory guidelines.
• Good written and verbal communication skills.
• Robust documentation, coordination, and organisational skills.

📌 QA/RA Associate (New Delhi)
🏢 Intrinseque Health
📍 New Delhi