The role includes developing, implementing, and maintaining quality management and regulatory compliance processes for clinical research activities and associated clinical supply chain operations. Day-to-day responsibilities involve reviewing and approving quality documentation, SOPs, and work instructions; supporting internal and external audits; and monitoring adherence to Good Manufacturing Practices (GMP) and relevant regulatory standards. The role also includes evaluating quality risks in clinical projects, coordinating with cross-functional teams to resolve quality and regulatory issues, and supporting continuous improvement initiatives.

The individual will collaborate with project management, operations, and regulatory teams to ensure that clinical trial materials, equipment, and processes meet applicable quality and regulatory requirements.

Qualifications

- Candidates should possess robust expertise in Quality Control and Quality Assurance, with experience applying these principles in clinical research, medical devices,



or pharmaceutical environments.
- Candidates should possess skills in Quality Management, including maintaining and improving quality systems, SOPs, and documentation aligned with industry standards and certifications.
- Candidates should possess knowledge of Good Manufacturing Practice (GMP) and the ability to interpret and implement GMP requirements across clinical supply and related operations.
- Candidates should possess experience in Quality Auditing, including planning, conducting, and following up on internal and external audits and inspections.
- Relevant qualifications such as a degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field; prior experience in clinical research, medical devices, or pharmaceuticals; and familiarity with international regulatory frameworks (e.g., ISO standards, ICH-GCP) are beneficial.

📌 QA & RA - Clinical Research (India)
🏢 Intrinseque Health
📍 India