Ragini Pandita
Associate Director Quality Assurance @Xencor
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WORK HISTORY
Associate Director Quality Assurance @Xencor
Pasadena, CA, US
Quality oversight for 4 programs at CMOs and CTOs to ensure product quality, regulatory compliance, and operational efficiency.• Work with cross-functional teams to implement and recommend process improvements.• Responsible for quality oversight of potency methods at CTOs.• Provide support for Quality Management Systems, Stability and Audit programs.
EDUCATION
University of Mumbai
MS, Biochemistry
Villanova University
Six Sigma Green Belt, Healthcare
ASQ
CQA, Certified Quality Auditor
UCLA Extension
Project Management
SKILLS
ABOUT RAGINI PANDITA
Quality Compliance Leader, Certified Quality Auditor and a Biochemist with 20 years of experience working globally within the biotech/pharmaceutical industry. Proven expertise in problem solving, data analysis, protocol authoring, risk assessment, FMEA, root cause analysis, metrics development and reporting, quality management and mentoring skills. Excellent proven project management skills in coordination with cross-functional teams and six sigma processes. Expertise in process development, aseptic processing and CGMP compliance. Proficient in Process, Assay, Equipment, Material and Cleaning Validation. Proficient in Computer System Validation, Data integrity, 21CFR11, 21CFR Part 210/211, ICH guidance and USP/EU regulations. Experience in successful collaboration with external testing laboratories and conducting internal and external audits.
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