The role includes managing and maintaining the organization’s Quality Management System (QMS) and ensuring compliance with applicable regulatory and quality requirements. The candidate will be responsible for developing, reviewing, and maintaining SOPs and quality documentation, supporting internal and external audits, and managing quality processes including CAPA, deviations, change control, and non-conformances. The role also involves ensuring compliance with relevant standards such as ISO 13485, ISO 9001, and GDP/GDPMDS requirements, maintaining quality records, and coordinating with cross-functional teams to ensure effective implementation of quality processes.

Qualification & Experience

• Bachelor’s degree in Pharmacy, Biotechnology, Life Sciences, Quality Management, or a related field.




• Hands-on experience working with QMS and quality documentation.
• Experience in preparing, reviewing, and implementing SOPs.
• Experience with ISO 13485 and ISO 9001 requirements.
• Experience with GDP/GDPMDS requirements.
• Practical experience in handling CAPA, deviations, non-conformances, and change control.
• Experience in internal and external quality audits and audit documentation.
• Valuable knowledge of quality compliance, documentation, risk management, and regulatory requirements.
• Strong documentation, analytical, communication, and cross-functional coordination skills.

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