Job Opportunity: QA Analyst – eTMF / GxP / 21 CFR Part 11
Summary:
Suzva Software Technologies is seeking a highly motivated and experienced QA Analyst specializing in eTMF, GxP, and 21 CFR Part 11 compliance to join our team in Chennai. This onsite role offers a unique opportunity to contribute to the quality assurance of global clinical systems within a regulated environment. The ideal candidate will possess a strong understanding of eTMF systems, GxP guidelines, ICH-GCP, and computer system validation (CSV), with a proven track record of ensuring compliance and supporting regulatory inspections. If you are passionate about clinical systems QA and eager to advance your career, we encourage you to apply.
About Suzva Software Technologies:
Suzva Software Technologies is a leading provider of innovative software solutions for the pharmaceutical and healthcare industries. We are committed to delivering high-quality, compliant solutions that meet the evolving needs of our clients. Our team is comprised of dedicated professionals who are passionate about technology and driven to make a difference.
Job Description:
As a QA Analyst specializing in eTMF / GxP / 21 CFR Part 11, you will be a key member of our Quality Assurance team, responsible for ensuring the quality and compliance of our clinical systems, particularly within the eTMF domain. You will play a critical role in system implementation, validation, and ongoing maintenance, ensuring adherence to GxP, 21 CFR Part 11, ICH-GCP, and other applicable regulatory guidelines.
Key Responsibilities:
- Lead and support eTMF system implementation and validation activities for platforms such as Veeva, Wingspan, ArisGlobal, and others.
- Ensure system compliance with GxP regulations, 21 CFR Part 11, ICH-GCP guidelines, and relevant regulatory requirements.
- Execute validation, functional testing, and compliance reviews for clinical and quality systems.
- Develop and review Computer System Validation (CSV) documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), test scripts, and validation reports.
- Support regulatory audits and inspection readiness activities, including preparing documentation and participating in audits.
- Collaborate with QA, Clinical, and IT teams to develop, maintain, and improve quality frameworks.
- Ensure all documentation is accurate, complete, and aligns with internal Standard Operating Procedures (SOPs) and global compliance expectations.
- Identify and escalate potential quality issues and risks to management.
- Contribute to the continuous improvement of QA processes and procedures.
Required Qualifications:
- Bachelor’s or Master’s degree in a relevant discipline (e.g., Computer Science, Life Sciences, Information Systems).
- 6-10 years of experience in QA, eTMF, GxP, CSV, or clinical systems quality assurance.
- Demonstrable expertise in:
- eTMF systems (Veeva / Wingspan / ArisGlobal).
- GxP compliance principles and practices.
- 21 CFR Part 11 requirements.
- ICH-GCP guidelines and their application to clinical systems.
- Computer System Validation (CSV) methodologies.
- Hands-on experience with developing and executing validation deliverables, including URS, FRS, IQ/OQ/PQ, and test scripts.
- Proven experience supporting regulatory inspections, including interaction with auditors and responding to findings.
- Strong understanding of software development life cycle (SDLC) principles and QA methodologies.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
Preferred Skills:
- Experience in clinical application QA, particularly within the pharmaceutical or biotechnology industry.
- Knowledge of quality systems and audit processes.
- Familiarity with industry best practices for eTMF management and CSV.
- Experience with automated testing tools and techniques.
- Strong documentation, communication, and cross-functional collaboration skills.
Benefits:
- Opportunity to work on global clinical systems and eTMF platforms, contributing to critical research and development efforts.
- Growth-oriented QA role within a challenging and rewarding regulated environment.
- Exposure to major audits and inspection activities, providing valuable professional development opportunities.
- Competitive compensation package commensurate with skills and experience.
- Comprehensive benefits package, including health insurance, paid time off, and professional development opportunities.
- Collaborative and supportive work environment.
To Apply:
If you meet the required qualifications and are interested in this exciting opportunity, we encourage you to submit your resume and cover letter for consideration. We look forward to hearing from you!