Emmes Group, a global clinical research organization with over 47 years of excellence, is hiring a Quality Assurance Specialist in Bengaluru, Karnataka (Remote). This is your opportunity to contribute to advancing medical discovery in a company that values both innovation and collaboration.
If you have a passion for clinical quality systems, computerized system validation, and regulatory compliance (21 CFR Part 11, GAMP 5), this role is the perfect fit.
🔍 About Emmes Group
Emmes Group is a trusted global CRO serving government, public-private, and biopharma sectors. With expertise in cell and gene therapy, vaccines, rare diseases, and neuroscience, Emmes is shaping the future of clinical research through innovation and technology — including its proprietary Veridix AI platform.
🧾 Key Responsibilities
As a Quality Assurance Specialist, you will:
- Review and audit computerized system validation documentation.
- Conduct internal and vendor audits for compliance.
- Support client audits and regulatory inspections.
- Manage CAPAs, deviations, and quality incidents.
- Evaluate suppliers and vendors for qualification.
- Contribute to process improvement initiatives.
- Write, review, and maintain corporate SOPs and policies.
- Conduct training sessions and maintain quality documentation.
🎓 Required Qualifications
- Bachelor’s degree in Life Sciences or related field.
- Minimum 1 year of experience in Quality Assurance within a regulated (GxP/ISO) environment.
- Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and related standards.
- Familiarity with security frameworks like NIST SP 800-53 or FISMA is a plus.
- Preferred Certifications: CQA, RAC, or RQAP.
💼 Why Join Emmes?
- Work remotely with a global team of clinical research professionals.
- Opportunity to contribute to next-generation medical innovations.
- Collaborative, inclusive culture focused on patient impact.
- Continuous learning and professional development.
📍 Job Details
- Position: Quality Assurance Specialist
- Company: Emmes Group
- Location: Bengaluru, Karnataka (Remote / India)
- Job Type: Full-time
- Experience: 1+ years
- Industry: Clinical Research, Quality Assurance
- Salary Range: ₹6,00,000 – ₹10,00,000 per annum (estimated)
