Executive

Lambda Therapeutic Research Ltd.; Ahmedabad District; On-site; INR 500,000 - 800,000; Full time

Job summary

Lambda Therapeutic Research Ltd. in Ahmedabad, India seeks a QA Auditor to plan and carry out in-process and retrospective audits across Clinical Pharmacology, Medical Affairs and QA functions.

The role includes reviewing SOPs, study reports, and regulatory documents, ensuring GLP compliance, and supporting sponsor inspections. The position involves audit report preparation, e-TMF document handling, and vendor assessments, with responsibilities extending to cross-functional collaboration and

Responsibilities

• Plan and carry out in-process audits of study activities in Clinical Pharmacology & Medical Affairs (Alco/Urine scan, informed consent, compliance check, dosing, meal distribution, phlebotomy, dispensing, sample separation).
• Conduct retrospective audits of study related raw data including ICFs, screening records, Trial Master File, IMP forms and clinical data like CRFs and listings (eCRF studies, PK/PD projects).
• Review SOPs for Clinical Pharmacology & Medical Affairs, QA, Biostatistics & Programming and cross functional departments for correctness and completeness.
• Review Clinical Study Reports, PK/statistical study reports and clinical study protocols retrospectively.
• Perform scheduled system audits, prepare audit reports and ensure compliance across departments.
• Review incident, investigation reports and SAP or other study documents.
• Review sponsor comments and monitoring observation responses.
• Verify dossiers for correctness and completeness; prepare Audit Certificates/QA Statements.
• Upload QA-related documents in e-TMF; review uploaded data in e-TMF.
• Audit vendors who are service providers to assess compliance.
• Support sponsor and regulatory inspections.
• Perform QA functions in line with OECD GLP principles and ensure compliance.
• Handle any other responsibilities as assigned by management / HOD.

Job description

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Company: Lambda Therapeutic Research Ltd.

CTC Range (INR): 500000 - 800000

• Plan and carry out In-process audits of study activities in Clinical Pharmacology & Medical Affairs department like Alco/Urine scan, informed consent presentation, compliance check, check-in, dosing, meal distribution, phlebotomy, dispensing, Sample separation etc.
• Conduct retrospective audits of study related raw data like Informed Consent Forms, Medical Screening records, Trial Master File, Investigation Medicinal Product forms, Clinical raw data like Case Record Forms, General Case Record Forms, listings in case of e-CRF studies, PK\ PD Projects etc.
• Review of Clinical Pharmacology and Medical Affairs, Quality Assurance, Biostatistics & Programming and other cross functional department SOPs for correctness, adequacy and completeness.
• Conduct retrospective review of Clinical Study Report, PK/statistical study report and clinical study protocol.
• Conduct system audit as per schedule, preparation of audit report and ensuring compliance in Clinical Pharmacology & Medical Affairs, Biostatistics & Programming and other cross functional department.
• Review of incident report, investigation report, Statistical Analysis Plan (SAP) or other study specific documents.
• Review of sponsor comments & Monitoring observation responses.
• Conduct the dossier verification for correctness and completeness.
• Preparation of Audit Certificate/Quality Assurance Statement.
• Uploading of QA related documents in e-TMF software.
• Review of uploaded data in e-TMF software.
• Conduct the vendor audits who are service providers to assess compliance.
• Providing support in sponsor and regulatory inspections.
• To perform QA functions as per OECD GLP principles and to ensure its compliance.
• Any other responsibilities as assigned by the management / HOD.