Lambda Therapeutic hiring Clinical QA Officer in Ahmedabad. M.Pharm with 2-3 years late phase QA experience. Salary up to 7 LPA.
Are you an M.Pharm graduate with hands-on experience in Clinical Quality Assurance? Here is a promising opportunity to work with a globally recognized Clinical Research Organization in Ahmedabad. This role is ideal for professionals with 2–3 years of late-phase QA experience who are looking to advance their careers in clinical audits, data review, and regulatory compliance within the CRO industry. Lambda Therapeutic Hiring Clinical QA Officer
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. The company provides comprehensive clinical research services to pharmaceutical innovators, biotechnology firms, and generic drug manufacturers worldwide.
With international operations in India, the United States, Canada, Spain, the United Kingdom, and Poland, Lambda offers end-to-end clinical trial solutions including bioavailability/bioequivalence studies, late-phase clinical trials, data management, regulatory services, and quality assurance oversight. The organization is known for its regulatory compliance standards and strong quality systems. Lambda Therapeutic Hiring Clinical QA Officer
Job Location & Employment Type
- Location: Ahmedabad, Gujarat, India
- Department: Clinical Quality Assurance
- Designation: Officer
- Employment Type: Full-Time
Open Positions / Department Details
The company is hiring for the position of Officer in the Clinical Quality Assurance (QA) function. The selected candidate will be responsible for ensuring that clinical trial activities, documentation, and data management processes comply with applicable regulatory requirements, internal quality standards, and client-specific protocols.
This position involves conducting audits at various stages of clinical studies and reviewing critical trial documentation before database lock and final reporting.
Key Roles & Responsibilities
The Officer – QA will play a vital role in maintaining quality standards across assigned clinical projects. Core responsibilities include: Lambda Therapeutic Hiring Clinical QA Officer
- Conducting routine in-process, on-site, and off-site audits to verify that trial-related activities are performed in compliance with regulatory and organizational requirements.
- Evaluating whether clinical data has been accurately recorded, analyzed, and reported according to approved protocols and contracts.
- Performing system audits as per the annual audit calendar to ensure adherence to Lambda’s SOPs, quality systems, and regulatory guidelines.
- Conducting retrospective audits of essential study documents such as:
- Informed Consent Forms (ICFs)
- Study Protocols
- Project Management Plans
- Investigational Medicinal Product (IMP) plans and release checklists
- Safety Management Plans (SMP)
- Clinical Study Reports
- Medical imaging documentation
- Assisting in completion and documentation of assigned system audits.
- Reviewing SOPs related to Clinical Data Management (CDM).
- Supporting preparation and revision of Quality Assurance SOPs.
- Auditing clinical databases and associated CDM documentation prior to database lock.
- Calculating error rates (%) in clinical databases and communicating findings to the Clinical Data Management team.
- Preparing CDM audit status summaries for inclusion in Audit Certificates or QA statements.
- Reviewing Data Management Plans (DMP), Statistical Analysis Plans (SAP – CDM aspects), and CRF/eCRF designs.
- Conducting system audits of Clinical Data Management processes and preparing comprehensive audit reports.
- Reviewing Trial Master File (TMF), Site Master File (SMF), site selection visit reports, and IMP release documentation.
This role requires strong analytical ability, documentation accuracy, and thorough knowledge of clinical regulatory requirements. Lambda Therapeutic Hiring Clinical QA Officer
Eligibility Criteria
Educational Qualification
- Master of Pharmacy (M.Pharm) – Mandatory
Candidates with specialization in Clinical Research, Pharmacology, or related disciplines may be preferred.
Experience
- 2–3 years of experience in late-phase Clinical Quality Assurance.
- Experience in conducting clinical audits and reviewing clinical trial documentation.
- Exposure to Clinical Data Management audits and database review processes.
- Familiarity with regulatory guidelines such as ICH-GCP and applicable global clinical trial standards.
Skills Required
- Strong understanding of clinical trial processes and regulatory frameworks.
- Knowledge of Good Clinical Practice (GCP) and quality management systems.
- Experience in auditing TMF, SMF, CDM documentation, and clinical databases.
- Ability to interpret protocols, contracts, and regulatory requirements accurately.
- Proficiency in preparing audit reports and compliance documentation.
- Strong analytical and attention-to-detail skills.
- Good written and verbal communication abilities.
- Ability to work independently and handle multiple audit assignments.
Lambda Therapeutic Hiring Clinical QA Officer
Salary & Benefits
- CTC Range: INR 5,00,000 – 7,00,000 per annum
- Additional benefits will be provided as per company norms.
This role offers competitive compensation along with exposure to global clinical research standards and international regulatory frameworks. Lambda Therapeutic Hiring Clinical QA Officer
Selection Process
The recruitment process may involve:
- Resume shortlisting based on QA experience.
- Technical interview focusing on clinical audit knowledge and regulatory compliance.
- Assessment of documentation and analytical skills.
- Final HR discussion and offer confirmation.
Only shortlisted candidates will be contacted for further evaluation.
How to Apply
Interested and eligible candidates should apply through the official career portal of Lambda Therapeutic Research Ltd. Candidates are advised to search for the position using the Req ID: 1219 while submitting their application.
Apply early to increase your chances of selection. Lambda Therapeutic Hiring Clinical QA Officer
Important Dates
- Application Deadline: Not specified
Why Apply for This Clinical QA Role?
This opportunity provides exposure to global clinical research projects and robust quality systems. Professionals selected for this role will benefit from:
- Direct involvement in late-phase clinical audits.
- Experience in CDM system audits and database review before lock.
- Exposure to international regulatory compliance frameworks.
- Career growth within a globally active CRO.
- Competitive salary package in Ahmedabad’s clinical research sector.
For QA professionals seeking structured growth in clinical auditing and compliance, this role offers long-term development potential. Lambda Therapeutic Hiring Clinical QA Officer
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform dedicated to sharing verified pharmaceutical and clinical research job opportunities. We are not affiliated with Lambda Therapeutic Research Ltd. or any other organization mentioned above. Candidates are advised to verify all details through the official company website before applying. We do not charge any fees for job postings or applications. Lambda Therapeutic Hiring Clinical QA Officer
If you meet the eligibility criteria and have experience in clinical quality assurance, apply now to advance your career in global clinical research. Lambda Therapeutic Hiring Clinical QA Officer
