Brillex Clinical Research Clinical Trial QA Jobs

Brillex Clinical Research Pvt. Ltd. is hiring for a Clinical Trial QA position.
The opportunity is open to candidates with B.Pharm or M.Pharm qualifications.
Candidates with 2–4 years of experience in Clinical Trial QA are eligible to apply.
The job location is Ahmedabad, Gujarat.

Brillex Clinical Research Pvt. Ltd. – Clinical Trial QA Department

Clinical Trial QA

• Qualification: B.Pharm / M.Pharm
• Experience: 2–4 years in Clinical Trial QA
• Job Location: Ahmedabad

Key Responsibilities

Brillex Clinical Research Pvt. Ltd. – Clinical Trial QA

• Review existing processes; develop and implement SOPs with relevant teams.
• Conduct clinical trial audits, including Investigator Site Audits, Site Selection Visits (SSVs), ISF audits, TMF audits, retrospective audits, and in-process audits.
• Conduct Vendor/Supplier Qualification and Re-qualification Audits.
• Review and approve clinical study documents such as protocols, study plans, DMP, SAP, IMP plans, IB, ICF, and Clinical Study Reports with a QbD approach.
• Perform data review and audit trail reviews of clinical systems such as CTMS, EDC, and eTMF.
• Perform statistical data review of mock shell, TLF, CDISC, etc.
• Identify quality risks, deviations, and compliance issues and support Root Cause Analysis (RCA) and CAPA.
• Support regulatory inspections and sponsor audits, including inspection readiness and CAPA responses.
• Work closely with Clinical Operations, Regulatory Affairs, Statistical, and Data Management teams.
• Identify opportunities for quality improvement and ensure continuous compliance.

Eligibility & Qualifications

Brillex Clinical Research Pvt. Ltd. – Clinical Trial QA

B.Pharm | M.Pharm

Experience

Brillex Clinical Research Pvt. Ltd. – Clinical Trial QA

2–4 years of experience in Clinical Trial QA

Job Location

Brillex Clinical Research Pvt. Ltd.

602, Ariane Legacy, Adalaj – Gandhinagar, Gujarat, India – 382421

How to Apply

Interested candidates with relevant experience can share their updated CV at:

Email: [email protected]

Candidates are encouraged to share this opportunity with suitable candidates.

Job Summary

Tagged as: Audit, CAPA, Clinical Operations, Clinical Research, Qualification, Regulatory Affairs