Simtra BioPharma Solutions

QA Engineer

• Manage the supplier change notification lifecycle, including evaluation, risk assessment, approval, tracking, and closure.
• Perform trend analysis of supplier quality data and proactively identify emerging risks.
• Review, analyze, and report supplier trends, including effectiveness and sustainability of corrective actions.
• Interface and collaborate with Supply Chain, Incoming Quality, Quality Assurance, Technical Services, Manufacturing, and other stakeholders to resolve supplier quality issues.
• Identify, document, and close gaps between Supplier Quality practices and corporate and local procedures, ensuring regulatory and procedural compliance.
• Guide and mentor peers in the application of statistically based quality engineering methodologies, including data analysis, interpretation of results, and risk-based decision making.
• Assess existing supplier quality processes and recommend improvements to enhance compliance, efficiency, and robustness.
• Support supplier qualification, performance monitoring, and ongoing quality development activities, including on-site and remote engagements.
• Participate in supplier audits, quality reviews, and business reviews as required.
• Ensure supplier quality activities comply with cGMP, global pharmacopoeias, and international regulatory expectations.
• Prepare and maintain clear, concise, and compliant documentation, metrics, and reports for internal and external stakeholders.

Principal Supplier Quality Engineer