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Qa Specialist Iii @Lonza
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WORK HISTORY
Qa Specialist Iii @Lonza
US
Supported end-to-end raw material quality control activities, including sampling coordination, testing decisions, sample distribution, and data management within Laboratory Information Management Systems (LIMS).• Created and maintained LIMS testing templates, ensuring accuracy and implementing corrections identified during data review.• Prepared and managed raw material documentation packets from receipt through release and final archiving, ensuring traceability and compliance.• Provided documentation support for quality systems, including Raw Material Qualification Reports and laboratory investigations.• Coordinated external raw material testing by preparing and managing outsourcing documentation and communication with third-party laboratories.• Utilized SAP to execute and support procedural and operational quality control activities.• Ensured strict adherence to Data Integrity (DI) principles in alignment with company policies, guidelines, and regulatory requirements.• Contributed to overall quality and compliance objectives by supporting cross-functional activities and continuous improvement initiatives.
EDUCATION
Shawsheen Valley Technical High School
Solid Works, Mechanical Drafting and Mechanical Drafting CAD/CADD
Veer Narmad South Gujarat University
Bachelor of Commerce (B.Com.), Mathematics and Statistics
ABOUT ASHFAQ TAI
Quality Specialist & Continuous Improvement | ASQ-Certified CQI & CSSGB.Driving Excellence in Regulatory Compliance, Lean Six Sigma, & Quality SystemsWith a strong foundation in ISO 9001, AS9100, GMP, and FDA/mil-spec compliance, I specialize in preventing defects, optimizing processes, and ensuring product integrity in highly regulated industries. My expertise spans:• GMP/cGMP, FDA regulations, and ISO 9001:2015 compliance.• Trained in Deviation Management System.• Drug Substance and Vaccine manufacturing pharmaceutical environment.• Support Deviations management, Change Control and CAPA.• SAP, Veeva Vault, OneDrive, MS Teams, Outlook, Excel, Word & Power Point.• Laboratory Inspection Management Systems (LIMS), Minitab, • QA Calibration and GMP equipment review.• GD & T Dimensional & Final Inspections, and Material Release.• Lean Manufacturing, Continues Improvement, Six Sigma 5S.• Microsoft Office applications: SharePoint, Outlook, Word, Excel & Power Point.• Incoming Material approval, Special Process Inspections• Manufacturing floor QA review support.• Job Aid drafting, SOP review and Quality Documentation for compliance. Industries Served: Aerospace (AS9100), Pharma/Medical (GMP, FDA), Specialty Metals (XRF testing, material release), and Defense.
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