The responsibilities include monitoring quality systems, reviewing clinical supply documentation, supporting audits and inspections, and verifying that devices and materials used in trials meet established quality and compliance criteria. The specialist will collaborate with project management, operations, and regulatory teams to identify issues, implement corrective and preventive actions, and continuously improve quality controls in clinical projects. The role also involves preparing quality reports, maintaining accurate records, and contributing to training and awareness on quality practices within the organization.

Qualifications

- Solid foundation in Quality Assurance and Quality Control, with experience applying these principles in clinical or life sciences environments.
- Knowledge of Quality Management systems, including implementation, monitoring, and continual improvement of quality processes.
- Understanding of Good Manufacturing Practice (GMP)



requirements and their application to clinical supplies and related activities.
- Experience with Quality Auditing, including planning, conducting, and documenting internal and external audits.
- Bachelor’s degree or higher in life sciences, pharmacy, biotechnology, engineering, or a related field.
- Ability to interpret regulations and standards relevant to clinical development and clinical supply chains.
- Strong attention to detail, documentation skills, and proficiency with standard office and quality management software tools.
- Effective communication and collaboration skills, with the ability to work in cross-functional, global teams.
- Prior experience in clinical research, clinical supplies, or medical devices quality is an advantage.

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