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iz-zebbug, malta
It's currently 11:10 PM here
Joined April 5, 2024
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Marylu P.
@marylupino
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iz-zebbug, malta
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Quality Leader & Business Consultant (PhD, MBA)
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Experience
Senior Quality Assurance Manager
Sep 2021 - Apr 2022 (7 months, 1 day)
Facility Quality Assurance Manager. Responsible for regulatory compliance and management of the Quality Management System for a leading wet wipe manufacturer in both cosmetic and medical device markets. Support Sanitary Manufacturing projects. Act as a SME in Product Design and Microbiology. Lead Quality Assurance Auditor. Support GMPs improvements and project plans. Assists in client and regulatory authority audits.
Quality Control Microbiologist Manager
Mar 2020 - Oct 2021 (1 year, 7 months)
Quality Control Team Leader - Microbiologist Lab Manager - SME Microbiology. Lead/Co-Lead Quality Auditor. Support Sanitary Manufacturing projects. Responsible for overseeing day-to-day operations of Microbiology Laboratory accredited ISO/IEC 17025:2017 for release of finished product and material, both cosmetic and medical device markets, in compliance with established regulations and company policies. Process validation. HACCP. CAPA. Trainer. Training and Documentation Procedures development.
Regional LAO Quality by Design Manager, Brazil & Colombia
Jan 2019 - Feb 2020 (1 year, 1 month)
SME Microbiology and Sanitary Manufacturing. Quality Design for Cosmetics & Toiletries. Regional Lead Quality Assurance Auditor for cosmetics, OTC, and medical devices on manufacturing sites (internal & suppliers), testing laboratories (internal & third-parties). Ensure operations and testing for release are conducted in compliance with established regulations (FDA, 21 CFR 210, 211, Health Canada GMP’s, ISO 9001, ISO 22716, ISO 13485, ISO/IEC 17025, ISO 14971, ISO 14155, etc.) CAPA. HACCP. PV.
Education
Master of Business Administration and Management
(1 year)
Professor, University Teaching of SciencesProfessor
(2 years)
Doctor of Philosophy - PhD, Microbiology & Biochemistry - Grade: 10 "Summa Cum Laude"
(5 years)
Qualifications
ISO 9001 Lead Auditor - Quality Certification
ISO - International Organization for Standardization / Bureau Veritas Group
2015
ISO 9001 Lead Auditor - Quality Certification
ISO 22716: 2007 GMPs for Cosmetic Products
Bureau Veritas Group
2012
ISO 22716: 2007 GMPs for Cosmetic Products
Lean Six Sigma Green Belt Certification – Level II
Universidad Tecnológica Nacional
2016
Lean Six Sigma Green Belt Certification
Publications
Changing epidemiology of extended-spectrum Beta-lactamases in Argentina: emergence of CTX-M-15.
Antimicrobial Agents Chemotherapy
2010 in Argentina, showed an increased prevalence of extended-spectrum β-lactamase (ESBL)-producing enterobacteria, with some changes in the molecular epidemiology of circulating ESBLs. While enzymes of the CTX-M-2 group remain endemic, the emergence of CTX-M-15 and of enzymes of the CTX-M-8 and CTX-M-9 groups was observed. The CTX-M-15-positive isolates represented 40% of CTX-M producers and included representatives of Escherichia coli ST131 and Klebsiella pneumoniae ST11.
Beta-Cyclodextrin hydrogels for the ocular release of antibacterial thiosemicarbazones.
Carbohydrate Polymers
The first method led to similar drug loads in all the hydrogels, with minor drug loss during the washing steps to remove unreacted monomers, while the second method evidenced the influence of structural parameters on the loading efficiency (proportion of CD units, mesh size, swelling degree). Microbiological tests against P. aeruginosa and S. aureus confirmed the ability of TSC-loaded pHEMA-co-β-CD network to inhibit bacterial growth. Carbohydrate Polymers · Apr 1, 2013
INQ-1, a chromosome-encoded AmpC Beta-lactamase from Inquilinus limosus.
Journal of Antimicrobial Chemotherapy
INQ-1 seems to be a cephalosporinase compatible with b-lactamases belonging to group 1 of the functional classification scheme. Although INQ-1 may not explain by itself all the observed resistance to b-lactams in the clinical isolate of I. limosus, it contributes to the overall increase in MICs for the INQ-1 producing E. coli clone, even if transcriptional and post-transcriptional impairments are due to the unusual start codon and high GC. J Antimicrob Chemother · Feb 1, 2014
Draft genome sequence of Inquilinus limosus strain MP06, a multidrug-resistant clinical isolate
Brazilian Journal of Microbiology
The bacterium, Inquilinus limosus, with its remarkable antimicrobial multiresistant profile, has increasingly been isolated in cystic fibrosis patients. We report draft genome sequence of a strain MP06, which is of considerable interest in elucidating the associated mechanisms of antibiotic resistance in this bacterium and for an insight about its persistence in airways of these patients. Pino M, Conza JD, Gutkind G. doi: 10.1590/s1517-838246420150474. Braz J Microbiol · Dec 1, 2015
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