This role is responsible for maintaining the Quality Management System (QMS) and ensuring compliance with applicable quality standards across clinical supply chain operations. It involves preparing and reviewing SOPs, managing deviations, CAPA, and change control, conducting root cause analysis and risk assessments, coordinating audits, maintaining quality documentation, and supporting continuous improvement initiatives. You will work closely with cross-functional teams to keep quality processes effective, documented, and audit-ready.

Qualifications

- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- 2-4 years of experience in Quality Assurance, preferably in the pharmaceutical, biotechnology, or clinical industry.
- Hands-on experience with QMS activities, including SOP preparation, review, revision, and document control.
- Experience in deviation management, including investigation, root cause analysis, impact assessment, and closure.
- Knowledge of CAPA management,



including action planning, implementation, effectiveness checks, and closure.
- Experience in change control management, including impact assessment, approvals, and implementation tracking.
- Familiarity with non-conformance management, risk management, and root cause analysis techniques.
- Experience coordinating internal, external, supplier, and customer audits, including preparation, findings, corrective actions, and closure tracking.
- Knowledge of document control, quality records, training documentation, and compliance trackers.
- Familiarity with GMP, GCP, GDP, and relevant ISO standards.
- Understanding of quality requirements for clinical trial materials, including storage, distribution, and transportation.
- Robust analytical, documentation, communication, and problem-solving skills.
- Proficiency in Microsoft Office, particularly Word and Excel.

📌 Quality Assurance Officer (New Delhi)
🏢 Intrinseque Health
📍 New Delhi