Personal Information
Organização/Local de trabalho
Greater Los Angeles Area, Gujarat United States
Cargo
Strategic GMP Consultant at Lupin Ltd. Biotechnology Division
Setor
Medical / Health Care / Pharmaceuticals
Site
zydus%2520biologics
Sobre
A Quality & DRA professional with width & depth of experience spanning 25+ yrs across key functions in pharma-biotech space
First-hand experience in negotiating with US FDA, CHMP and MHRA.
Extensive hands on experience on all Injectable / Parenteral Dosage Forms (Prefilled syringes / Vials / Lyophilized Vials / Multi dose pen) and Solid Dosage forms.
Quality management system, Design and Execution:Layout design,detailed engineering,Validation of facility,Water system, equipment,method,process,Cleaning validation,Computer/electronic System,Change control,Deviation,OOS,OOT,Investigation,CAPA,Maintenance & Preventive maintenance, Stability testing, Quality Control, Batch Control & Product...
Marcadores
fdagmp
tga
gmp
compliance
mhra
it
glp
system
regulatory
audit
computer
integrity
validation
qc
qa
usfda
quality management
r & d
learning
leadership
ich q8
quality
q9
qms
risk management
training
soft skills
letter
who
483
warning
csv
manufacturing
dmf
pharmaceutical
data
invited speaker
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