Lambda Therapeutic Research Ltd., a globally recognized Clinical Research Organization (CRO), is hiring an experienced Officer – Quality Assurance (QA) for its Ahmedabad location. This opportunity is ideal for M.Pharm professionals with 2–3 years of late-phase QA experience who are seeking stable CRO jobs in India with strong regulatory exposure.
This role focuses on clinical data management audits, system audits, TMF/SMF review, and regulatory compliance, making it highly relevant for candidates targeting QA jobs in clinical research, CRO QA officer roles, and ICH-GCP audit careers.
🏢 Company Overview
Lambda Therapeutic Research Ltd. is a global, full-service CRO headquartered in Ahmedabad, India, with international operations in the USA, Canada, UK, Spain, and Poland. Lambda provides end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies, with a strong reputation for quality systems and regulatory compliance.
📋 Job Details
- Job Title: Officer – Quality Assurance
- Req ID: 1219
- Location: Ahmedabad, Gujarat
- Company: Lambda Therapeutic Research Ltd.
- CTC Range: ₹5,00,000 – ₹7,00,000 per annum
- Experience: 2–3 years (Late Phase QA)
- Education: M.Pharm
- Job Type: Full-time
🧪 Key Responsibilities
- Conduct in-process, on-site, off-site, and retrospective audits for assigned clinical studies
- Ensure compliance with ICH-GCP, regulatory guidelines, Lambda SOPs, and client protocols
- Perform and report system audits as per the annual audit calendar
- Audit ICFs, protocols, PMP, IMP plans, SMP, CSRs, and medical imaging documents
- Review and support Clinical Data Management (CDM) SOPs and QA documentation
- Audit clinical databases prior to database lock
- Calculate clinical database error rates and prepare CDM audit status reports
- Review DMP, SAP (CDM aspects), eCRF/CRF designs
- Conduct CDM system audits and prepare detailed audit reports
- Review TMF, SMF, site selection visit reports, and IMP release checklists
🎓 Qualifications & Experience
Mandatory Requirements
- M.Pharm qualification
- 2–3 years of experience in late-phase Quality Assurance
- Strong understanding of clinical data management audits
- Hands-on experience with TMF, SMF, SOPs, and regulatory inspections
Preferred Skills
- Knowledge of ICH-GCP, CDSCO, US FDA, EMA guidelines
- Strong documentation and audit reporting skills
- CRO audit experience is highly desirable
💼 Salary & Benefits
- Competitive CTC: ₹5–7 LPA
- Exposure to global clinical trials
- Strong learning curve in regulatory audits and CDM QA
- Career growth within a reputed global CRO
- Professional work environment with compliance-driven culture
📝 How to Apply
