Position Title

Head - Quality Assurance (QA)

Department

Quality Assurance

Reporting To

Test Facility Management

Location

Bangalore

Employment Type

Full time

Key Responsibilities

Quality Assurance Programme Management
Lead and manage the GLP Quality Assurance Unit (QAU).
Develop, implement, and maintain an effective quality management system aligned with OECD GLP principles and ISO 17025.
Ensure independence of the Quality Assurance Unit from study conduct activities.
Establish annual QA plans, inspection schedules, and risk-based audit programmes.
Monitor compliance with regulatory requirements and industry best practices.

GLP Compliance Oversight
Verify that studies are planned, performed, monitored, recorded, reported, and archived in accordance with approved protocols, SOPs, and GLP requirements.
Ensure compliance with OECD GLP Principles and applicable national regulatory requirements.
Conduct periodic reviews of quality systems to identify potential compliance gaps.
Maintain readiness for regulatory inspections and external audits.





Inspections and Audits
Plan, conduct, supervise, and review:
Facility inspections
Process inspections
Study-based inspections
Data audits
Raw data reviews
Archival inspections
Supplier and subcontractor audits
Prepare inspection reports and communicate findings to Test Facility Management and Study Directors.
Verify implementation and effectiveness of corrective and preventive actions (CAPA).

Study Monitoring
Review study protocols, protocol amendments, and final reports from a QA perspective.
Monitor critical phases of ongoing studies.
Verify accurate recording of raw data and traceability of study activities.
Provide QA statements for final study reports in accordance with GLP requirements.

Documentation and SOP Management
Oversee creation, review, approval, implementation, and periodic revision of Standard Operating Procedures (SOPs).
Ensure document control systems

📌 Head Qa Bengaluru
🏢 Tuv Sud South Asia PrivateLimited
📍 Bengaluru