Afzal Arshad

I am a Supplier Quality Engineer with 4+ years of experience supporting pharmaceutical, biotech, and life sciences manufacturing under FDA, ISO, and GMP regulations. I specialize in supplier quality management, CAPA coordination, SCAR execution, and process validation to reduce defects and ensure CtQ characteristics.

I have led root cause investigations, PFMEA, MSA, SPC, and APQP activities, and executed PV&V and IQ/OQ/PQ efforts while managing supplier audits, qualifications, and documentation using tools such as Windchill and SAP. My work has included FAI/PSW support, supplier performance tracking, and driving corrective and preventive actions to improve compliance and prevent recurrence.

I hold an M.S. in Engineering Management and a B.Eng. in Mechanical Engineering, and I am Lean Six Sigma Green Belt certified. I bring a data-driven continuous improvement mindset, strong technical foundation, and cross-functional collaboration skills to ensure quality systems and processes meet regulatory and customer requirements.