2013 -2013 Batch Record Review SME @ Validant (Patheon, Mexico City)
2012 -2012 Quality Systems Specialist @
2011 -2012 Quality Assurance and Regulatory @
2008 -2011 MFG QA Specialist @ Obagi Medical Products
Luis Sastre Education
Universidad de Puerto Rico
Bachelor of Science (BS) (Microbiology, General)
1983-1991
UPR Arecibo
Bachelor of Science (BS) (Microbiology, General)
1983-1991
Luis Sastre Skills
GMP
Validation
Quality Assurance
Batch Records
Change Control
CAPA
GLP
FDA
Sop
21 CFR Part 11
GxP
V&V
LIMS
FDA GMP
Cleaning Validation
Quality Control
Aseptic Processing
Technology Transfer
Quality System
Computer System Validation
Biopharmaceuticals
Regulatory Affairs
ISO 13485
Regulatory Requirements
Regulatory Submissions
Trackwise
Luis Sastre Summary
Luis Sastre, based in Boston, MA, US, is currently a Quality Assurance Senior Specialist at Fagron Sterile Services US (FSS). Luis Sastre brings experience from previous roles at Editas Medicine, Moderna, Fresenius Kabi USA and Softworld. Luis Sastre holds a 1983 - 1991 Bachelor of Science (BS) in Microbiology, General @ Universidad de Puerto Rico. With a robust skill set that includes GMP, Validation, Quality Assurance, Batch Records, Change Control and more. Luis Sastre has 2 emails and 2 mobile phone numbers on RocketReach.
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