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
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