Brillex Clinical Research Pvt. Ltd. has announced a Clinical Trial QA job opening in Ahmedabad for pharmacy professionals with experience in clinical trial quality assurance.
The position is suitable for B.Pharm and M.Pharm graduates with 2–4 years of relevant Clinical Trial QA experience. The selected professional will work across clinical quality systems, audits, SOP management, TMF and ISF reviews, vendor qualification, clinical data review, CAPA management, and regulatory inspection readiness.
This Clinical Trial Quality Assurance job in Ahmedabad offers exposure to multiple functions including Clinical Operations, Regulatory Affairs, Data Management, and Statistics.
Job Overview
| Particular | Details |
|---|---|
| Company | Brillex Clinical Research Pvt. Ltd. |
| Position | Clinical Trial QA |
| Department | Clinical Quality Assurance |
| Qualification | B.Pharm / M.Pharm |
| Experience | 2–4 years in Clinical Trial QA |
| Location | Ahmedabad, Gujarat |
| Industry | Clinical Research / CRO |
| Employment Type | Full-Time |
| Application Mode |
Key Responsibilities
Candidates selected for the Clinical Trial QA position may be responsible for:
- Reviewing existing quality processes and supporting the development and implementation of Standard Operating Procedures (SOPs) with relevant functional teams.
- Conducting clinical trial audits, including Investigator Site Audits, Site Selection Visit (SSV) audits, ISF audits, TMF audits, retrospective audits, and in-process audits.
- Conducting vendor and supplier qualification and re-qualification audits.
- Reviewing and approving clinical study documentation, including protocols, study plans, Data Management Plans (DMP), Statistical Analysis Plans (SAP), IMP plans, Investigator’s Brochures (IB), Informed Consent Forms (ICF), and Clinical Study Reports (CSR).
- Performing clinical data reviews and audit-trail reviews using systems such as CTMS, EDC, and eTMF.
- Performing statistical data reviews covering mock shells, TLFs, CDISC-related outputs, and associated clinical trial deliverables.
- Identifying quality risks, protocol/process deviations, and regulatory compliance issues.
- Supporting Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) activities.
- Supporting sponsor audits and regulatory inspections, including inspection-readiness activities and CAPA responses.
- Collaborating with Clinical Operations, Regulatory Affairs, Statistics, and Data Management teams.
- Identifying quality-improvement opportunities and helping maintain continuous compliance with applicable clinical research quality requirements.
Qualification and Eligibility
Candidates interested in this Clinical Trial QA job in Ahmedabad should meet the following requirements:
Educational Qualification:
B.Pharm or M.Pharm
Experience:
2–4 years of relevant experience in Clinical Trial Quality Assurance / Clinical Research QA.
Candidates with practical knowledge of clinical trial audits, GCP quality systems, TMF/ISF review, SOPs, CAPA, vendor audits, and clinical systems such as CTMS, EDC, and eTMF will be particularly relevant for the position.
Key Skills
Relevant skills for this Clinical Trial QA vacancy include:
Clinical Trial QA, GCP, Clinical Trial Auditing, Investigator Site Audit, TMF Audit, ISF Audit, Vendor Audit, SOP Development, CAPA, RCA, Inspection Readiness, CTMS, EDC, eTMF, Clinical Data Review, Audit Trail Review, Clinical Quality Management and Regulatory Compliance.
Why Consider This Clinical Trial QA Role?
The position provides an opportunity to gain cross-functional exposure across several important areas of clinical research quality assurance. Professionals can work with clinical trial documentation, investigator-site and TMF audits, electronic clinical systems, vendor qualification, quality risk management, CAPA, and regulatory inspection readiness.
The role may be particularly relevant for pharmacy professionals looking to strengthen their careers in Clinical Quality Assurance, GCP auditing, clinical compliance, and quality management within the CRO/clinical research industry.
How to Apply
Eligible candidates can prepare an updated CV highlighting their Clinical Trial QA, GCP audit, TMF/ISF audit, CAPA, SOP, vendor audit, CTMS, EDC, and eTMF experience.
Send the updated CV to:
Email: rushabhshah@brillexcro.com
Candidates should mention the Clinical Trial QA position clearly while applying.
Company: Brillex Clinical Research Pvt. Ltd.
Job Location: Ahmedabad, Gujarat, India
