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Join Veeda Lifesciences, a global contract research organization (CRO) with USFDA-approved facilities, as a Quality Assurance Auditor at our Ahmedabad office. Contribute to high-quality clinical research with a focus on compliance and excellence.
Job Details
- Role: Quality Assurance Auditor
- Experience: 4-6 Years
- Qualification: Not specified (B.Pharm / M.Pharm / M.Sc preferred, based on industry standards)
- Location: Ahmedabad, Gujarat
- Job Code: Not specified
Key Responsibilities
Document Review
- Conduct QA review of study-specific documents (Protocol, ICF, Patient Diary, Clinical Study Report) for compliance with SOPs, ICH-GCP, Indian GCP, and regulatory requirements
- Review essential documents for clinical trials (Phase I-IV, BA/BE studies) to ensure adherence to protocols and regulations
- Evaluate study-specific plans (e.g., Project Management Plan, Data Management Plan) for compliance
Audit Activities
- Plan, conduct, and report study-based audits for clinical trials, ensuring compliance with ICH-GCP, Indian GCP, and internal procedures
- Perform clinical trial site/investigator audits and issue audit certificates
- Conduct system audits, vendor/supplier audits, in-process audits (IMP distribution, dispensing, labelling), TMF audits, and GxP audits
- Verify audit compliance and manage CAPA closure
Quality Management System
- Prepare, review, update, and finalize QA SOPs; review system SOPs
- Manage CAPA, Change Control, Deviation, and process improvement activities
- Assist in incident/event investigations and software validation as QA
- Ensure QA document control, distribution, archiving, and database/tracker updates
- Perform trend analysis and identify system/process gaps for improvement
- Support guideline/regulation interpretation and attend scheduling meetings
Desired Profile
- 4-6 years of experience in quality assurance auditing for clinical trials or BA/BE studies
- Strong knowledge of ICH-GCP, Indian GCP, and regulatory requirements
- Hands-on experience with audits (study, site, vendor, TMF, GxP) and CAPA management
- Proficiency in SOP development, document review, and QMS processes
- Excellent analytical, communication, and organizational skills
- Ability to work independently and in cross-functional teams
Why Join Veeda Lifesciences?
Veeda Lifesciences, rated 3.8/5 on AmbitionBox for employee satisfaction, is a leading CRO with 700+ employees in India, offering clinical, preclinical, and bioanalytical services. Our Ahmedabad headquarters, rated 3.6/5 for work culture, fosters skill development and innovation. Learn more at Veeda Lifesciences.
How to Apply
- Email: Send CV to mahendra.t3705@veedalifesciences.com.
- Include: Updated CV, educational certificates, and recent payslips.
- Note: This is not a walk-in interview. USFDA/GCP exposure preferred.
Additional Information
Explore QA career trends at PharmaVoice. Join Veeda to ensure quality in clinical research!
Disclaimer: Veeda Lifesciences does not charge fees for recruitment. Verify offers through official channels.
Note: Shortlisting based on qualifications, experience, and regulatory expertise.