SAUL SEGURA-SOLIS
Mexico city,MEX
Summary
Bilingual professional with 7+ years of experience in the management and operation of QC microbiology laboratories. Highly organized and capable of working in a team environment. Deep understanding of international regulatory guidelines (FDA/EU) and GxP.
Overview
7
7
years of professional experience
Work History
Quality Specialist
UNILEVER
12.2022 - Current
- In charge of the continuous improvement of the overall quality control system: SOPs, change controls, deviations, CAPA and risk analyses
- Lead and coordinate regulatory inspections (FDA, MHRA, PMDA)
- Training (skills-based, cGMP and safety) of associates
- Test method verification, qualification, validation and/or transfer
- Manage department resources (stock, instruments, lab operation/scheduling)
QC Microbiology (Contractor)
Bristol-Myers Squibb
03.2022 - 12.2022
- On site work for the CAR-T cell (ABECMA & BREYANZI) manufacturing facility
- Review/Approval of laboratory test data according to Global Regulatory and cGMP requirements
- Opening and follow up of laboratory quality events, deviations, and invalid assays
- Use of LIMS and EDMS systems
Microbiology leader
GSK Consumer Healthcare
01.2021 - 01.2022
- Supervise and assist staff members, oversee testing methods, and present the results to the QC manager
- Make sure that all tests and projects were completed on a timely manner
- Plan, organize, and coordinate daily lab activities, instrument maintenance, troubleshooting, incidences record
- Generation of QC reports (tracking and trending)
- Draft and review technical documents
- Microbiology method transfer
- Environmental monitoring plan implementation.
- Environmental monitoring qualification.
QC Senior Microbiologist
MEGALABS
01.2020 - 01.2021
- Perform microbiological testing methods and the proper use of laboratory equipment (Enumeration test, bioburden, Sterility test, BET test).
- Document data GMP accurately and within the proper system
- Participate in projects and continuous improvement efforts
- Instrument maintenance and troubleshooting
- Prepare and present improvement projects to management
- Environmental monitoring qualification
QC Senior Microbiologist
Laboratorios Pisa
01.2018 - 01.2020
- Perform routine Microbiological Examination testing on drug product, raw materials, and stability samples in accordance to written methodology
- Media preparation, inoculum suspension preparation and autoclave sterilization
- Data review, trending & tracking, opening and follow up of deviations (OOS, OOT)
- Troubleshoot instrument problems
- Draft and review technical documents, such as SOPs and protocols/reports
- Prepare and present improvement projects to management
Education
COURSES - Pharma Marketing
Mexico Valley University (UVM)
01.2022
COURSES - Project Execution, Monitoring, and Control
Mexico Valley University (UVM)
01.2021
B.s. - Chemical Bacteriology and Parasitology
National School of Biological Sciences (ENCB), National Polytechnic Institute (IPN)
08.2016
Skills
Microbiology test methods
Biochemistry assays
Aseptic Technique
Environmental Monitoring
Bioburden
Endotoxin
Water and gas sampling
QRT-PCR, SAP
Veeva and Trackwise
Leadership, Critical thinking and problem solving
Languages
Spanish
English
Workingstatus
TN-2 VISA (No sponsorship)
References
Julie Magarra, QC Microbiology, Bristol-Myers Squibb, 973-460-3098, Juliegamarra@gmail.com
Timeline
Quality Specialist
UNILEVER
12.2022 - Current
QC Microbiology (Contractor)
Bristol-Myers Squibb
03.2022 - 12.2022
Microbiology leader
GSK Consumer Healthcare
01.2021 - 01.2022
QC Senior Microbiologist
MEGALABS
01.2020 - 01.2021
QC Senior Microbiologist
Laboratorios Pisa
01.2018 - 01.2020
COURSES - Project Execution, Monitoring, and Control
Mexico Valley University (UVM)
B.s. - Chemical Bacteriology and Parasitology
National School of Biological Sciences (ENCB), National Polytechnic Institute (IPN)
COURSES - Pharma Marketing
Mexico Valley University (UVM)
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