QA Auditor role at Lambda CRO. Conduct clinical trial audits (on-site/off-site) for late-phase studies. 2-3 yrs QA exp in clinical research & M.Pharma degree required. Apply now.
Guardian of Quality & Compliance in Global Clinical Research
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) with a strong heritage and strategic presence across North America, Europe, and Asia. Our headquarters in Ahmedabad is the hub for scientific and operational excellence, ensuring the integrity of clinical trials that shape the future of medicine.
We are seeking a meticulous and principled Quality Assurance Auditor to join our team at our Ahmedabad headquarters. In this critical role, you will be the independent guardian of quality, conducting audits to ensure all trial activities and data meet stringent regulatory, organizational, and client requirements. This position focuses on late-phase clinical research, offering you the opportunity to develop deep expertise in ensuring the robustness of data and processes that support drug approvals and lifecycle management.
Your Mission: Ensure Integrity Through Independent Verification
As a QA Auditor, you will conduct systematic, evidence-based evaluations of clinical trial activities and documentation. Your objective assessments are vital for maintaining compliance, identifying risks, and upholding Lambda's reputation for quality and reliability with our global clients.
Key Responsibilities
1. Clinical Trial & System Auditing
- Conduct routine audits (In-process, On-site, and Off-site) at various trial stages to verify that all activities are performed, recorded, and reported in compliance with regulatory requirements (ICH-GCP, etc.), Lambda SOPs, and client protocols.
- Perform and report system audits as per the annual calendar, assessing compliance with quality systems and processes.
- Conduct retrospective audits of critical study documents including Informed Consent Forms (ICF), protocols, Clinical Study Reports (CSR), and safety management documents.
2. Data Integrity & Documentation Oversight
- Audit the clinical database and CDM documents prior to database lock, ensuring data integrity and accuracy.
- Calculate and report the % error rate for the clinical database to the Data Management team for corrective action.
- Review the Trial Master File (TMF), Study Master File (SMF), and other essential regulatory documentation.
3. Process Review & Quality System Support
- Review and contribute to SOPs pertaining to Clinical Data Management (CDM) and Quality Assurance.
- Review key project plans including the Data Management Plan (DMP), Statistical Analysis Plan (SAP), and e-CRF/CRF design.
- Assist in the completion of assigned system audits and support continuous improvement initiatives within the QA function.
Who You Are: The Ideal Candidate
You are a detail-oriented professional with a strong ethical compass and a systematic approach to work. You possess a foundational understanding of clinical research processes and derive satisfaction from ensuring accuracy and compliance.
Your Required Foundation:
- Educational Qualification: M.Pharma degree is required.
- Experience: 2-3 years of direct experience in Quality Assurance within a clinical research setting, specifically with exposure to late-phase (Phase III/IV) trials.
- In-depth knowledge of ICH-GCP guidelines and global clinical trial regulations.
- Familiarity with clinical trial documentation, including protocols, CSRs, TMF, and data management processes.
- Exceptional attention to detail, analytical skills, and objectivity.
- Strong written and verbal communication skills for clear audit reporting.
- Ability to work independently and manage multiple audit assignments.
What Will Make You Stand Out:
- Experience conducting on-site investigator site audits.
- Formal training or certification in clinical research auditing.
- Understanding of risk-based quality management (RBQM) principles.
Why Build Your QA Career at Lambda in Ahmedabad?
1. Central Role in a Global CRO
- Perform a mission-critical function that directly impacts client trust and regulatory success.
- Gain broad exposure to all aspects of clinical trial operations from the perspective of quality and compliance.
2. Structured Career Progression
- Develop specialized expertise in late-phase clinical trial auditing.
- Clear pathway to Senior Auditor, QA Manager, or compliance specialist roles within our growing global organization.
3. Purpose-Driven & Professional Environment
- Work at the headquarters of a respected, employee-owned global CRO.
- Be part of a culture that values scientific integrity, quality, and professional growth.
Ready to Uphold the Highest Standards of Clinical Research?
If you are a quality-focused M.Pharma graduate with auditing experience, looking to apply your skills in a dynamic global environment, we want to hear from you.
Apply now to become a key defender of quality at Lambda's Ahmedabad headquarters.
