This role is responsible for supporting quality assurance activities across clinical supply chain operations, including ensuring compliance with relevant ISO standards, internal SOPs, and regulatory requirements. Day-to-day responsibilities include reviewing and maintaining quality documentation, participating in audits and inspections, monitoring quality metrics, and identifying areas for process improvement. The specialist will collaborate with project management, operations, and regulatory teams to ensure that clinical supplies, equipment, and devices meet quality standards throughout the trial lifecycle.

The role also involves training site and internal teams on quality procedures, contributing to risk assessments, and supporting corrective and preventive actions.

Qualifications

- Candidates should possess quality assurance and quality control skills, including experience with ISO 13485, ISO 9001, and related quality management systems.
- Candidates should possess project coordination and documentation skills, including attention to detail, record-keeping, SOP management, and report writing.
- Candidates should possess robust analytical and problem-solving skills, with the ability to support risk assessment, root cause analysis,



and continuous improvement initiatives.
- Candidates should possess effective communication and collaboration skills to work with cross-functional teams, site staff, and external partners.
- Relevant qualifications include a bachelor’s degree in life sciences, pharmacy, biomedical engineering, or a related field; a master’s degree or specialized certification in quality or clinical research is an advantage.
- Prior experience in clinical quality assurance, medical devices, or clinical supply chain in the biopharmaceutical or healthcare industry is highly beneficial.
- The candidate should have experience handling CAPA, including root-cause investigation, corrective/preventive actions, and effectiveness checks.
- 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.

📌 Quality Assurance, Clinical Specialist (New Delhi)
🏢 Intrinseque Health
📍 New Delhi