Jignesh Shah
Pqts Manager @Seres Therapeutics
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WORK HISTORY
Pqts Manager @Seres Therapeutics
Waltham, MA, US
EDUCATION
L.M. College Of Pharmacy
Diploma in Pharmacy, Pharmacy, A
Stevens Institute of Technology
Master’s Degree, Pharmaceutical Manufacturing Engineering, 3.6 out of 4.0
Shri Sarvajanik Pharmacy College, Hemchandracharya North Gujarat University
Bachelor's Degree, Pharmacy, A
ABOUT JIGNESH SHAH
MS with 11+ years of cGMP experience in Pharma & Biotech QC to support testing, stability studies and disposition/release of Raw Materials, Drug Substance and Drug Product, LVV, Plasmid, mRNA • Area of expertise- Manage QC testing at various CTL - SME for various Analytical techniques and lab instruments - Technical Writing, CMC, Stability Studies, Data Trending - Method Qualification, Method Validation and Method Transfer - Quality Systems (e.g. Lab investigations, Deviations, CAPAs and Change Controls)- Lab improvement projects and Operational Excellence Projects (5S, Role cards, etc.) • Onboarding, Training and Mentoring new employees in cGMP QC lab and Virtually • Scheduling of daily lab activities • Knowledge of FDA, 21 CFR, ICH guidelines, compendia like USP, Ph. Eur. And JP • Excellent knowledge of LIMS, Trackwise, SAP, Veeva, MasterControl, Empower, MS Office • Trouble shooting skills, Strong organizing skills, Interpersonal skills, Time-management skills
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