Roles & Responsibilities
• Plan, conduct, and manage internal audits including in-process, retrospective, and system audits
• Perform vendor audits as per audit plans and regulatory requirements
• Prepare and issue audit reports to auditees in a timely manner
• Review and prepare SOPs, clinical study protocols, and clinical study reports
• Assess audit responses and negotiate appropriate corrective and preventive actions (CAPA)
• Review deviations and CAPA plans and ensure timely implementation and closure
• Support preparation for client, sponsor, and regulatory inspections
• Reconcile project and non-project documents and coordinate archival activities
• Review equipment calibration and validation records
Qualification
• Bachelor’s or Master’s degree in Life Sciences (B.sc, M.sc/ B.Pharm / M.Pharm)
Experience
• 2–5 years of experience in GCP Quality Assurance audits
• Strong knowledge of ICH-GCP guidelines
• Working knowledge of US, EU regulations, and applicable GxP standards
Skills
• Strong written and verbal communication skills
• Excellent analytical and problem-solving abilities
• Good computer proficiency
• Self-motivated with strong prioritization and time-management skills
About the Organization
Jeevan Scientific Technology Limited is a global life sciences services organization providing clinical research, quality assurance, regulatory, and medical writing services to pharmaceutical and biotechnology companies, ensuring compliance and quality across the product development lifecycle.
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