Gunjan Amin

Environmental Condition Manager @Andelyn Biosciences

Columbus, OH, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Aug 2022 — Present

Environmental Condition Manager @Andelyn Biosciences

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Columbus, OH, US

EDUCATION

2004 — 2009

The Ohio State University

Bachelor of Science (B.S.), Microbiology, General

SKILLS

Corrective and Preventive Action (Capa)Bacterial EndotoxinChange ControlHazmat CertificationMicroscopyQuality AssuranceLaboratoryTest for Specified MicroorganismsPcr Antimicrobial Effectiveness TestingGlpHplcContainer Closure Integrity TestingAseptic TechniquePharmaceutical IndustrySopFda Method ValidationStandard Operating Procedure (Sop)Analytical Method ValidationU.s. Title 21 Cfr Part 11 RegulationCapaQuality SystemU.s. Food and Drug Administration (Fda) Bioburden Testing Preparing MediaMicrobiology Microbial IdentificationEndotoxin Challenge VialGood Laboratory Practice (Glp)BiotechnologyValidationEnvironmental MonitoringQuality ControlGmp

ABOUT GUNJAN AMIN

I am an experienced leader with over 15 years of experience in Quality Control Microbiology and Environmental Monitoring with expertise in Method Validation protocols, Transfer and Process Validation, Microbial Contamination control, and Root Cause Investigations & CAPA. I have a forward-looking approach to integrating eco-friendly practices and experience supporting pre-approval inspection (PAI)/GMP inspection by FDA, EMA, ANVISA, and Health Canada for the Greenfield facility. I am knowledgeable in cGMP, 21 CFR, PDA, ISO, ICH / USP / EP, and FDA Guidance documents related to the pharmaceutical industry.Areas of Expertise o Aseptic Media Fill Programo Microbial Contamination control o Environmental Monitoring programso Root Cause Investigations & CAPAo Process Validation o Sterility Testingo Bacterial Endotoxin Testingo Microbial Limits Testing & Organism Identificationso Media preparation and Growth Promotion Testingo Container Closure Integrity Testing

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