Are you an M.Pharm professional with experience in late phase Quality Assurance (QA)? Lambda Therapeutic Research Ltd. is hiring an Officer โ Quality Assurance in Ahmedabad, offering a competitive CTC of โน5โ7 LPA. This is an excellent opportunity for candidates seeking clinical QA jobs in Ahmedabad, CRO quality assurance careers, and roles in clinical data management audit within a globally recognized Clinical Research Organization (CRO).
Lambda Therapeutic Research is a global full-service CRO with operations across India, USA, Canada, Spain, UK, and Poland, providing comprehensive clinical research services to innovators and pharmaceutical companies worldwide.
๐ Job Overview โ Officer (Quality Assurance)
- Company: Lambda Therapeutic Research Ltd.
- Location: Ahmedabad, Gujarat, India
- Experience: 2โ3 years (Late Phase QA)
- Qualification: M.Pharm
- Salary Range: โน5,00,000 โ โน7,00,000 per annum
- Job Type: Full-time
This Quality Assurance Officer job in a CRO focuses on auditing, compliance verification, and clinical database review to ensure adherence to regulatory, organizational, and client-specific requirements.
๐งพ Key Responsibilities
1๏ธโฃ Clinical Trial & System Audits
- Conduct in-process, on-site, and off-site audits across assigned clinical projects
- Perform system audits as per annual audit calendar
- Ensure compliance with Lambda SOPs, Quality Systems, and regulatory guidelines
- Assist in completion of assigned system audits
2๏ธโฃ Retrospective & Documentation Audits
- Audit raw study data including:
- Informed Consent Forms (ICFs)
- Protocols & Project Management Plans
- IMP plans & release checklists
- Safety Management Plans (SMP)
- Clinical Study Reports
- Medical Imaging documents
3๏ธโฃ Clinical Data Management (CDM) Audit
- Audit clinical database before database lock
- Calculate and report % error rate in clinical database
- Prepare CDM audit status for QA statement / Audit Certificate
- Review:
- Data Management Plan (DMP)
- Statistical Analysis Plan (SAP โ CDM aspects)
- eCRF/CRF design
- TMF, SMF, Site Selection Visit reports
4๏ธโฃ SOP & Compliance Review
- Review SOPs related to Clinical Data Management
- Prepare and review SOPs related to Quality Assurance
- Conduct system audits of CDM and prepare audit reports
๐ Eligibility Criteria
- Educational Qualification: M.Pharm
- Experience: 2โ3 years in late phase QA
- Strong knowledge of:
- ICH-GCP guidelines
- Clinical trial auditing
- CDM processes
- Regulatory compliance
- Audit reporting & documentation
๐ผ Why Consider This CRO QA Job?
- Opportunity to work in a global clinical research organization
- Exposure to late phase clinical trial QA operations
- Strong career growth in clinical quality assurance and regulatory compliance
- Hands-on experience with CDM audit and database validation
- Competitive salary structure (โน5โ7 LPA)
๐ฉ How to Apply
