The candidate should have hands-on experience in Quality Assurance and QMS within a regulated healthcare/clinical setting, with strong knowledge of SOPs, ISO 13485, ISO 9001, GDPMDS, CAPA, deviations, and clinical QA processes.

Qualification

- The candidate should be responsible for maintaining and implementing the Quality Management System (QMS).
- The candidate should prepare, review, update, and maintain SOPs, quality policies, work instructions, and related documentation.
- The candidate should ensure compliance with ISO 13485 and ISO 9001 requirements.
- The candidate should have experience handling CAPA, including root-cause investigation, corrective/preventive actions, and effectiveness checks.

The candidate should have a Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
- The candidate should manage deviations, non-conformances, investigations,



documentation, and closure.
- The candidate should support internal and external quality audits and assist with audit observations and corrective actions.
- The candidate should maintain quality records and ensure proper documentation, traceability, and compliance.
- The candidate should have exposure to GDPMDS requirements and related quality processes.
- The candidate should support clinical QA activities, including review and maintenance of relevant quality documentation.
- The candidate should coordinate with cross-functional teams to ensure adherence to quality and regulatory requirements.
- The candidate should contribute to QMS improvement and inspection/audit readiness.

📌 Clinical Executive - Quality Assurance (India)
🏢 Intrinseque Health
📍 India