Job Title: Officer – Quality Assurance (Late Phase)
Req ID: 1219
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 5,00,000 – 7,00,000 per annum
Experience Required: 2–3 years
About Lambda Therapeutic Research
Lambda Therapeutic Research Ltd. is a globally established, full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operational hubs in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), Lambda delivers end-to-end clinical research solutions to global pharmaceutical, biotech, and generic drug companies.
Job Summary
Lambda Therapeutic Research is seeking a Quality Assurance Officer – Late Phase to support audit activities and ensure compliance across clinical trials and clinical data management systems. This role focuses on audit execution, documentation review, system compliance, and quality oversight in alignment with regulatory, organizational, and client requirements.
Key Responsibilities
Conduct in-process, on-site, and off-site audits to verify that clinical trial activities, data recording, analysis, and reporting comply with applicable regulatory guidelines, internal SOPs, and client protocols.
Perform and report system audits as per the annual audit calendar to ensure compliance with Lambda SOPs, quality systems, protocols, and regulatory requirements.
Execute retrospective audits of study-related documentation, including Informed Consent Forms, protocols, project management plans, IMP documentation, Safety Management Plans, Clinical Study Reports, and medical imaging-related records.
Assist in the completion of assigned system audits and support overall audit readiness activities.
Review and contribute to Standard Operating Procedures (SOPs) related to Clinical Data Management (CDM) and Quality Assurance.
Audit clinical databases and Clinical Data Management documentation prior to database lock.
Calculate clinical database error rates before database lock and communicate findings to the CDM team.
Prepare CDM audit status reports for inclusion in Audit Certificates and QA statements.
Review Data Management Plans (DMPs), Statistical Analysis Plans (SAPs – CDM aspects), and CRF/eCRF designs for assigned projects.
Conduct system audits of Clinical Data Management processes and prepare detailed audit reports.
Review Trial Master File (TMF), Study Master File (SMF), site selection visit reports, and IMP release checklists for completeness and compliance.
Required Experience
2–3 years of experience in Late Phase Quality Assurance within a CRO or pharmaceutical environment.
Practical exposure to clinical data management audits, system audits, and regulatory compliance activities.
Sound knowledge of ICH-GCP guidelines, SOP frameworks, and clinical trial documentation.
Educational Qualification
Master of Pharmacy (M.Pharm) is mandatory.
Why Join Lambda Therapeutic Research
Opportunity to work with a globally recognized CRO on international clinical research projects.
Strong focus on quality systems, compliance, and professional development.
Structured career growth within clinical quality assurance.
Competitive compensation aligned with industry standards.
Apply Now:
Explore this opportunity and apply through ThePharmaDaily.com to advance your career in Clinical Quality Assurance with Lambda Therapeutic Research.
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