The role involves managing and maintaining clinical quality processes and ensuring compliance with applicable regulatory and quality standards. The candidate should have hands-on experience in CAPA, deviation management, QMS, SOPs, audits, and clinical quality assurance, with solid knowledge of ISO 13485, ISO 9001, and GDPMDS requirements.

Qualifications

- The candidate should have 3-6 years of experience in Clinical QA / Quality Assurance, preferably within the medical device, healthcare, pharmaceutical, or clinical environment.
- The candidate should have hands-on experience in CAPA management, deviation investigation, root cause analysis, and effectiveness checks.
- The candidate should have experience in developing, reviewing, implementing, and maintaining SOPs and Quality Management Systems (QMS).
- The candidate should have practical knowledge of ISO 13485, ISO 9001, and GDPMDS requirements.




- The candidate should be experienced in internal and external audits, including audit preparation, documentation, observations, and corrective actions.
- The candidate should have exposure to clinical QA activities, quality documentation, compliance monitoring, and maintaining quality records.
- The candidate should be able to identify quality risks, support investigations, and ensure timely closure of quality-related issues.
- The candidate should have strong documentation, analytical, communication, and coordination skills.
- Educational Qualification: Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, Biomedical Sciences, or a related field.

📌 Clinical QA Specialist (New Delhi)
🏢 Intrinseque Health
📍 New Delhi