Quality Assurance Specialist III

Overview

Quality Assurance Specialist III provides independent QA support for GLP and GCLP studies, focusing on data integrity, traceability, and compliance while maintaining separation from study execution.

What you'll do

• Support internal study audits by creating study-specific audit schedules prior to First patient-in.
• Create audit plans, execute scheduled audits, and draft objective, evidence-based audit reports under QA lead oversight.
• Perform QA reviews of controlled documents to verify SOP alignment and version verification.
• Conduct protocol and experiment record reviews, including sampling of experiment or batch records against protocols.
• Assess data integrity across paper and electronic records, including audit trails, metadata, and system controls.
• Apply ALCOA+ principles and assess compliance with 21 CFR Part 11 / Annex 11 for electronic systems.
• Provide audit preparation support, including checklists, pre-audit document packages, and draft audit summaries.

What you'll need

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, or Chemistry.
• 4 years of related experience in a life science GxP environment with CRO experience preferred.
• Hands-on experience with ICH-GCP (E6 R2/R3).
• Knowledge of FDA regulations (e.g., 21 CFR Part 11) and EMA / EU CTR / Annex 11 GxP frameworks (GCP, GMP, GLP, GCLP).
• High attention to detail and strong written/verbal communication skills.
• Experience with data review across computerized systems including LIMS, plus understanding of audit trails and metadata.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and the ability to work independently with minimal supervision.

Details

• Location: Bangalore, Karnataka, India.