Quality Assurance Specialist III

Overview

Quality Assurance Specialist III provides independent QA support for GLP and GCLP studies, including audits, document/record review, data integrity assessments, and quality event oversight. The role maintains independence from study execution and includes some remote-capable QA activities with controlled system access.

What you'll do

• Support internal audits by creating a study-specific audit schedule prior to FIP.
• Create audit plans, execute scheduled audits, and draft evidence-based audit reports under QA lead oversight.
• Review controlled documents for SOP alignment and version verification.
• Conduct QA review (sampling) of experiment and batch records, including alignment with protocol-defined activities and recorded execution.
• Perform QA review against DTA of data tables, listings, and summaries, including traceability and internal consistency checks.
• Conduct data integrity audits of paper and electronic records, assessing audit trails, system controls, and data lifecycle controls.
• Assist with audit preparation tasks such as checklists, pre-audit document packages, evidence lists, and draft reports/summaries.

What you'll need

• 4 years of related experience in a life science GxP environment with CRO experience preferred.
• Bachelor’s degree or Master’s degree in Life Sciences, Pharmacy, Biology, or Chemistry.
• Hands-on experience with ICH-GCP (E6 R2/R3).
• Knowledge of FDA regulations including 21 CFR Part 11.
• Familiarity with EMA/EU CTR/Annex 11 within GxP frameworks (GCP/GMP/GLP/GCLP).
• High attention to detail and ability to meet deadlines.
• Data review expertise across computerized systems including LIMS and understanding of audit trails, metadata, and system validation.

Details

• Location: Bangalore, Karnataka, India.
• Some QA activities can be performed remotely with controlled system access and separation from operational responsibilities.