Dave Kuchta

Director of Quality and Regulatory @Safetec Of America, Inc

Buffalo, NY, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2023 — Present

Director of Quality and Regulatory @Safetec Of America, Inc

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Buffalo, NY, US

In this position, I have a leadership role in site Quality and Regulatory operations- Oversee company Quality and Regulatory Affairs compliance systems- Work with company administration to provide Quality, Regulatory, and technical inputs on company Product Development projects- Collaborate with Manufacturing and Engineering counterparts to complete company continuous improvement projects- Member of company Senior leadership team- Oversee compliance requirements for Drug, Medical Device, Cosmetic, and EPA based OTC products.

EDUCATION

1979 — 1985

Buffalo State University

MA Biology, Microbiology,Cell Biology,Botany

1979 — 1981

Buffalo State University

BA, Biology

SKILLS

IsoPharmaceutical IndustrySopFdaAsq Certified as a CssgbContinuous ImprovementComputer System ValidationGampInternal and External AuditorFda GmpLimsRegulatory SubmissionsTrainer in BiomanufacturingMedical DevicesCapaQuality ControlGmpPharmaceuticsExperienced Manager for Life Science CompaniesLaboratoryBiopharmaceuticalsCleaning ValidationMicrobiologyPharmaceutical MicrobiologistChange ControlIso 13485Technology TransferTrackwiseRegulatory RequirementsValidationGlpSterilizationRegulatory AffairsLifesciences21 Cfr Part 11Six SigmaQuality AuditingAseptic ProcessingChemistryPharmaceutical and Medical Device Quality Experience

ABOUT DAVE KUCHTA

A Life Science professional with experience administering ISO and Quality Management Systems in the Drug, Medical Device, OTC Monograph, Cosmetic, and Chemical Excipient Industries.* Trained Pharmaceutical Microbiologist.* Instructor of GMP industry training for Life Science companies (workforce development and professional continuing education).* Professional Certifications from the American Society for Quality *Certified ASQ Auditor and Biomedical Auditor.*Certified ASQ Six Sigma Green Belt *Certified Quality Improvement AssociateSpecialties-State University of New York at Buffalo -Life Science Advisor and Instructor COILS program-(Career Opportunities in Life Sciences) Millard Fillmore College SUNY at Buffalo-SUNY, Erie Community College (Buffalo, NY), Instructor-Certificate Program in Biomanufacturing, Advisory Board Member to Biomanufacturing Program Management skills training-Cornell University,(School of Industrial and Labor Relations Certificate program in Management Studies)

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Dave Kuchta — Director of Quality and Regulatory at Safetec Of America, Inc in Buffalo, NY, US | Unifers