Leonel Monteiro Da Silva work email
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Leonel Monteiro Da Silva personal email
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Multilingual & multicultural Quality and Operations Vice President with approximately 20 years of local as well as international experience in the pharmaceutical industry, holding a Masters in Pharmaceutical Sciences and a MBA. Developed and maintained local and global teams, Quality Management Systems and its tools, successfully managed plenty of international inspections of world authorities (FDA, TGA, Anvisa, GCC, etc) while exporting to 70 plus countries worldwide. Successfully led a local organization (>500 people) as Plant Manager while implementing a quality and operations turnaround to ensure license and certification maintenance and an investment of 15 Mio €. Successfully guided and developed up to 12 site quality organizations within Europe, Asia, Africa and Latin America striving for harmonization and synergies. Also involved on successful divestment activities. Expert on sterile (Aseptic and Terminally Sterilized) with additional experience in non-sterile forms, all as an EU certified Qualified Person.Hard Skills: GxPs, Quality Management Systems, Inspection Management, Sterile Manufacturing, Global and Local team management, Product LifecycleSoft Skills: Inspiring & Passion, Commitment & Empowerment, Teamwork, Creativity & Innovation, Complex Problem Solving, Openminded, Logical Thinking, Agile, Strategic & Purpose Mindset
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Vp Qa Global PharmaFresenius KabiPorto, Pt
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Vp Qa Global Iv FluidsFresenius Kabi Aug 2024 - PresentBad Homburg, Hessen, DeCommitted to Life & Striving for Quality Excellence while leading, coordinating and supporting a group of 8 global pharma and medical devices manufacturing sites within Europe and Latin America.
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Vp Quality Assurance Europe & AsiaFresenius Kabi Jan 2022 - Aug 2024Bad Homburg, Hessen, DeStriving for Quality Excellence while leading, coordinating and supporting a group of up to 10 global pharma and medical devices manufacturing sites within Europe and Asia.Main Achievements: - Successfully implemented a Quality Culture Excellence Program to increase Q awareness throughout Quality and Operations.- Successfully implemented the harmonization of SOPs (>100) across the regions aiming a common QMS and language.- Effectively implemented a QA and QC efficiency program to increase digitalization, seamless processes and efficiency. - Divested a plant ensuring successfully that it would remain as a CMO of Fresenius Kabi.
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Senior Director Quality Assurance Europe & South AfricaFresenius Kabi Jan 2021 - Dec 2021Bad Homburg, Hessen, DeStriving for Quality Excellence while leading, coordinating and supporting a group of up to 12 global pharma and medical devices manufacturing sites within Europe and Asia.Main Achievements: - Successfully implemented a Quality Culture Excellence Program to increase Q awareness throughout Quality and Operations.- Successfully implemented the harmonization of SOPs (>100) across the regions aiming a common QMS and language.- Effectively implemented a QA and QC efficiency program to increase digitalization, seamless processes and efficiency.
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Plant Manager & Executive DirectorFresenius Kabi Oct 2018 - Dec 2020Bad Homburg, Hessen, DeManaged and led a sterile manufacturing site of 550+ people, responsible for Production, Quality, HR, Supply Chain and IT with close collaboration with local and international markets.Main Achievements: - Successfully implemented a remediation plan aiming for a quality culture turnaround and a comprehensive operational transformation to ensure manufacturing license granting, GMP certification maintenance and business continuity specially within COVID.- Successfully managed an investment of €15 Mio on a new sterile manufacturing line and the revamping of existing ones.- Tech-transferred and launched several new molecules into the region.- Effectively managed a diverse and multicultural Site Leadership Team through guidance, empowerment and promoting accountability.
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Director Qa Europe And South AfricaFresenius Kabi Aug 2017 - Sep 2018Bad Homburg, Hessen, DeReported Directly to VP QA Global Operations being responsible for the QA support, compliance and coordination of 4 manufacturing plants within Europe and South Africa.
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Qualified PersonFresenius Kabi Aug 2012 - Sep 2018Bad Homburg, Hessen, DeQualified Person regarding aseptically filled dry powders for Local and International markets.Batch certification according to applicable Marketing Authorization and concerning GMP guidelines.
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Site Quality HeadFresenius Kabi Jul 2013 - Oct 2017Bad Homburg, Hessen, DeQuality Assurance head for 4 manufacturing units with several pharmaceutical technologies from aseptic filling, TS to oral dosage forms. Direct report to Corporate Operations QA. Managing a team of 20 plus elements.Main Achievements:- Effectively re-designed the QMS in order to face the transition from a local supplying plant to a Global supplying plant. Harmonized policies and SOPs, digitalized QM-Tools, implemented one Quality language across the site for inspection readiness.- Successfully managed site certifications and re-certifications from authorities all around the world- Efficiently released and supported the supply of 70+ countries worldwide- Successfully created a local QM-Tools Software (Deviations, Change Controls, CAPAs)- Was part of the global design team for the implementation of Trackwise® (QMS Software), serving a landscape of 60+ organizations of pharma & medical devices around the world
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Gmp Compliance DirectorFresenius Kabi Mar 2011 - Jul 2013Bad Homburg, Hessen, DeWithin the Quality Unit manages the GMP Compliance Department, encompassing the following duties and responsibilities: > cGMP Compliance Assessment: evaluate processes compliance according to applicable cGMPs regarding several technologies from aseptic filling, TS to oral dosage forms for Local and International markets;> Suppliers Qualification Mgmt: assess, evaluate, audit , establish quality agreements and document the entire qualification process for APIs, Packaging Materials Suppliers and Service Providers;> QM Tools Mgmt: develop IT based tools, manage, monitor and KQIs reporting; Deviations, CAPAs, Changes, Complaints , Recalls and Returns Management.> Audits and Inspections Mgmt: audit planning; escorting of auditors/inspectors (EU and ROW); self-inspection planning and execution; follow-up> Internal and External Auditor> cGMP Trainer> Management and Oversight of Aseptic Practices and Hygienic conduct; Personnel Qualification> Development of Local Quality Policies and High Level SOPs;
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Gmp Compliance ManagerFresenius Kabi Jun 2009 - Feb 2011Bad Homburg, Hessen, DeWithin the Q-Unit:cGMP ComplianceSuppliers QualificationCAPA mgmtContinuous Improvement
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Quality Assurance OfficerFresenius Kabi Jul 2005 - May 2009Bad Homburg, Hessen, DeDeviations and CAPA mgmtChange Control mgmtComplaints and recalls mgmtSuppliers Qualification mgmtcGMP TrainerAuditor
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Responsible Person DeputyCommunitary Pharmacy 2001 - 2005Qualified Person deputy. Managing a team of 6 elements.
Leonel Monteiro Da Silva Skills
Leonel Monteiro Da Silva Education Details
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Universidade De CoimbraPharmaceutical Sciences -
Fresenius KabiAdministração De Empresas
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Porto Business SchoolExecutive Mba
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Universidade De AveiroBiomolecular Sciences
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Universidade De CoimbraPharmaceutical Sciences
Frequently Asked Questions about Leonel Monteiro Da Silva
What company does Leonel Monteiro Da Silva work for?
Leonel Monteiro Da Silva works for Fresenius Kabi
What is Leonel Monteiro Da Silva's role at the current company?
Leonel Monteiro Da Silva's current role is VP QA Global Pharma.
What is Leonel Monteiro Da Silva's email address?
Leonel Monteiro Da Silva's email address is le****@****ail.com
What schools did Leonel Monteiro Da Silva attend?
Leonel Monteiro Da Silva attended Universidade De Coimbra, Fresenius Kabi, Porto Business School, Universidade De Aveiro, Universidade De Coimbra.
What skills is Leonel Monteiro Da Silva known for?
Leonel Monteiro Da Silva has skills like Gmp, Pharmaceutical Industry, Capa, Quality Assurance, Validation, Quality Management, Quality System, Pharmaceutics, Change Control, Sop, Regulatory Affairs, Gxp.
Who are Leonel Monteiro Da Silva's colleagues?
Leonel Monteiro Da Silva's colleagues are Артем Барбанаков, Shama Talwar, Leydi C., Fredrik Ekeberg, Evandro Akio Adachi Suda, Richard Nival, Mohammed Elmadhoun.
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