The role involves ensuring quality standards and compliance within clinical operations by maintaining Quality Management Systems (QMS), managing deviations, CAPAs, SOPs, and supporting quality audits. The candidate will help ensure compliance with applicable regulatory and quality requirements, including ISO 13485, ISO 9001, and GDPMDS, while maintaining accurate quality documentation and supporting continuous improvement activities.

Qualifications:
• Maintain and monitor the Quality Management System (QMS).
• Handle deviations, CAPA, and quality-related documentation.
• Prepare, review, and maintain SOPs and quality records.
• Support internal and external audits and regulatory compliance activities.
• Ensure adherence to applicable ISO 13485, ISO 9001,



and GDPMDS standards.
• Identify quality gaps and support corrective and preventive actions.
• Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
• 2–3 years of experience in Quality Assurance within a clinical, pharmaceutical, or healthcare-related workplace.
• Knowledge of QMS, CAPA, deviations, SOPs, and quality audits.
• Understanding of ISO 13485, ISO 9001, and GDPMDS requirements.
• Good documentation, communication, and organizational skills.

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