Bachelor of Science (BS) (Industrial Technology, Quality Assurance, and Computer Electronics Minor-Business)
1988-1992
Adamjee Cantonment College
Bachelor's Degree (Biology, General)
1977-1980
Michael Abraham Skills
Validation
CAPA
FDA
GxP
Biotechnology
Quality Assurance
V&V
Quality System
Computer System Validation
GMP
21 CFR Part 11
IND
Quality Control
Clinical Development
Change Control
CRO
Cleaning Validation
GLP
GCP
Regulatory Affairs
Quality Management
Biopharmaceuticals
cGMP
Auditing
Technology Transfer
Regulatory Submissions
CTMS
Process Validation
Document Management
EDC
Pharmaceuticals
Quality Systems
Quality Auditing
ISO 13485
LIMS
Validations
GAMP
Clinical Trials
Regulatory Requirements
ISO
CMC
Data Center
Electronics
PLC
Analytical Chemistry
QC
Process Development
HPLC
EU Annex- 11
IT Infrastucture Qualification in GxP environment
Equipment Qualification
Sales
Development
Aseptic Fill and Finish
Validation of Uf/Df Process
Strategic Planning
Downstream Processing
Iso14971
Microsoft Office
Eu Annex 11
Cmo/Cro Management
Process Engineering
Training
Manufacturing
CRO Management
Michael Abraham Summary
Michael Abraham, based in Hayward, CA, US, is currently a Head of Global Clinical and Pharmacovigilance and Safety Vigilance Quality at Santen. Michael Abraham brings experience from previous roles at Santen, Quark Pharmaceuticals, Zogenix, Inc. and Pfizer. Michael Abraham holds a 1988 - 1992 Bachelor of Science (BS) in Industrial Technology, Quality Assurance, and Computer Electronics Minor-Business @ San Jose State University. With a robust skill set that includes Validation, CAPA, FDA, GxP, Biotechnology and more. Michael Abraham has 4 emails and 1 mobile phone numbers on RocketReach.
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