The role includes supporting and maintaining quality standards across clinical and operational processes. The role includes managing QMS documentation, SOPs, CAPA, deviations, non-conformances, audits, quality investigations, and compliance activities, while ensuring processes align with applicable regulatory and quality requirements.
Qualifications
• Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, Microbiology, or a related field
• Minimum 2–3 years of relevant experience in Clinical QA / Quality Assurance is mandatory
• Bachelor’s/Master’s degree in Pharmacy, Biotechnology, Life Sciences, or a related field
• Robust knowledge of Quality Management Systems (QMS)
• Experience in SOP preparation, review, implementation, and maintenance
• Hands-on experience in CAPA management
• Experience in deviation and non-conformance management
• Experience in quality investigations and root cause analysis
• Experience in internal and external audits
• Knowledge of GxP and applicable regulatory requirements
• Experience in quality documentation and compliance monitoring
• Ability to support quality improvement and compliance initiatives
• Strong written and verbal communication skills
• Ability to work effectively with cross-functional teams
📌 Clinical Specialist, Quality Assurance (New Delhi)
🏢 Intrinseque Health
📍 New Delhi
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