Position Summary
The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review, protocol and experiment record review, data review, and quality event oversight activities. The role focuses on ensuring data integrity, traceability, and compliance with internal SOPs and applicable regulatory expectations, while maintaining strict independence from study execution.

This position includes high‑value QA activities that can be performed remotely, with controlled system access and explicit separation from operational responsibilities.

Essential Duties Include But Are Not Limited To
Study-Audit Support

Support Execution Of Internal Audits By- Create study-specific audit schedule prior to First patient-in (FIP) for study-specific audit
Create audit plan, execute, and draft the report for each scheduled audit (interim or associated with the final report) using objective, evidence-based language under QA lead oversight
Execute the audit through the review of controlled document, including:
SOP alignment
Version verification




Study governing documents (Lab manual, Project Specification Document, Data Transfer Agreement, clinical protocol)
Conduct QA review of clinical protocols, sample analysis protocols (SAP/SAR) and amendments, ensuring:
Version verification
Internal consistency
Alignment with study objectives and SOPs
Assure closure of quality events pertaining to study at the time of data reporting
Perform QA review (sampling) of experiment records / batch records, including:
Need access to LIMS/BSI and other systems hosting data source
Ensure alignment between protocol-defined activities and recorded execution
Training status of staff
Qualification status of equipment and reagents
Conduct QA review (sampling) against DTA of data tables, listings, and summaries, including:
Table-to-source traceability (raw data → output)
Internal consistency checks
Sample ID reconciliation and data alignm

📌 Quality Assurance Specialist Iii Bengaluru
🏢 Precision for Medicine
📍 Bengaluru