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Suzva Software Technologies is hiring an experienced QA Analyst – eTMF / GxP / 21 CFR Part 11 for an onsite role in Chennai. This opportunity is ideal for professionals with strong skills in eTMF system implementation, GxP compliance, ICH-GCP, and computer system validation (CSV).
If you’re looking to advance your career in clinical systems QA, this opening provides a high-impact role in a regulated environment.
Key Responsibilities
- Lead and support eTMF system implementation and validation activities (Veeva, Wingspan, ArisGlobal, etc.).
- Ensure system compliance with GxP, 21 CFR Part 11, ICH-GCP, and applicable regulatory guidelines.
- Execute validation, functional testing, and compliance reviews for clinical and quality systems.
- Review and prepare CSV documentation including URS, FRS, IQ/OQ/PQ, test scripts, and validation reports.
- Support regulatory audits and inspection readiness activities.
- Collaborate with QA, Clinical, and IT teams to maintain quality frameworks.
- Ensure all documentation aligns with internal SOPs and global compliance expectations.
Required Qualifications
- 6–10 years of experience in QA, eTMF, GxP, CSV, or clinical systems quality.
- Strong expertise in:
- eTMF systems (Veeva / Wingspan / ArisGlobal)
- GxP compliance
- 21 CFR Part 11
- ICH-GCP guidelines
- Computer System Validation (CSV)
- Hands-on experience with validation deliverables: URS, FRS, IQ/OQ/PQ, test scripts.
- Experience supporting regulatory inspections.
- Bachelor’s or Master’s degree in any relevant discipline.
Preferred Skills
- Experience in clinical application QA.
- Knowledge of quality systems and audit processes.
- Strong documentation, communication, and cross-functional collaboration skills.
Benefits
- Opportunity to work on global clinical systems and eTMF platforms.
- Growth-oriented QA role within a regulated environment.
- Exposure to major audits and inspection activities.
- Competitive compensation based on skills and experience.
How to Apply
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