Job Title: Officer – Clinical Quality Assurance (QA)
Req ID: 1219
Date: January 13, 2026
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range (INR): 500,000 – 700,000
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With strategically located facilities in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we deliver end-to-end clinical research solutions to global innovators, biotech companies, and pharmaceutical organizations.
Our mission is to uphold the highest standards in clinical research, quality assurance, and regulatory compliance, ensuring reliable, accurate, and safe data for clinical development.
We are seeking a detail-oriented Officer – Clinical Quality Assurance (QA) to perform audits and reviews of clinical trials, data management activities, and regulatory compliance. The role focuses on ensuring that clinical trial activities are conducted, recorded, and reported accurately, in line with global regulatory requirements, organizational SOPs, and client-specific protocols.
Conduct in-process, on-site, and off-site audits of clinical trials to verify adherence to regulatory, organizational, and client requirements.
Perform system audits as per the annual audit calendar to ensure compliance with Lambda SOPs, quality systems, protocol requirements, and regulatory guidelines.
Conduct retrospective audits of study-related documents including Informed Consent Forms (ICFs), protocols, project management plans, IMP release checklists, Safety Management Plans (SMPs), Clinical Study Reports, and medical imaging records.
Assist in the execution and reporting of assigned system audits.
Review and prepare SOPs related to Clinical Data Management (CDM) and Quality Assurance.
Audit clinical databases and data management documents prior to database lock, calculating error rates and providing feedback to the CDM team.
Review Data Management Plans (DMPs), Statistical Analysis Plans (SAPs), and e-CRF/CRF designs for clinical data management projects.
Conduct system audits of clinical data management and prepare audit reports.
Review Trial Master File (TMF), Site Master File (SMF), site selection visit reports, and IMP release checklists to ensure compliance.
Prepare CDM audit status reports for incorporation into Audit Certificates and QA statements.
2–3 years of experience in late-phase clinical Quality Assurance or related QA activities.
Strong knowledge of clinical trial processes, data management, and regulatory compliance.
Experience in auditing clinical databases, SOPs, and study documentation.
M. Pharm in Pharmacy, Life Sciences, or a related field.
Work in a global CRO with exposure to international clinical trials and regulatory standards.
Gain hands-on experience in clinical quality assurance, audits, and regulatory compliance.
Opportunity for career growth and exposure to multiple therapeutic areas, clinical systems, and quality processes.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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