
Daniel Martins Porto
Tecnical Manager - Qualified Person

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About me
Sr. Post-Market Surveillance Manager
Education

Fundação Getulio Vargas
2011 - 2012Especialista MBA Manufacturing & Quality ManagementMBA Manufacturing and Quality Management.

Universidade Federal de Minas Gerais
1999 - 2004Bacharel Industrial pharmacyBachelor of Science in Pharmacy
Experience

Indubras
Mar 2004 - May 2012Tecnical Manager - Qualified PersonIndubras is a veterinary pharmaceutical and nutritional products manufacturer. My position was Technnical Manager, commanding manufacturing activities , regulatory affairs, quality control and quality assurance . Planning and production control manager. Lead auditor in internal and external audits . Mediator between the company regulation agencies. Contract manager. I reported to the company president.Main achievements:Development of architectural projects for new production sites; GMP and Validation Master Plan implementation; Stablishment of new production processes aiming manufacturing costs reduction and production maximization; Implementation of ERP system as a key user of product engineering, production planning and process control modules. Show less

Labcor Laboratórios Ltda
Jun 2012 - Apr 2017Labcor is a class 3 medical devices manufacturer, ISO 9001, 13485 and GMP certified, with several CE Mark products. My position is production manager, commanding directly a team of supervisors, coordinators, production analysts and approximately 110 employees. Planning and production control manager. Top management representative in external audits for maintenance of QMS certification. Internal auditor certified with ISO 19011 standard. I refer directly to the scientific director.Main achievements: MRP system implementation; GMP and clean room training for production crew; Development of productivity award system, resulting in absenteeism reduction; Products yield maximization; KPI program and continuous improvement quality tools implementation; Stablishment of new production processes aiming operational costs reduction and Lean Manufacturing philosophy. Show less
Production Manager
Jan 2014 - Apr 2017Production and Supply Chain Supervisor
Jun 2012 - Jan 2014

Dutch Ophthalmic Research Center
Apr 2017 - Nov 2019• Member of the Product Management and R&D team and responsible for product development projects for the Liquids business portfolio. Responsible for €1M+ projects for product development and production location transfer;• Coordination and prioritization of resources, managing interfaces of several projects including budget and risks, proactively reporting issues and proposing mitigation. Leading multidisciplinary project teams without being their manager;• Full lifecycle management for existing products, representing 25% of company sales budget;• Product development: products R&D, writing patents, identification of contract manufacturers and leading relationship. Building technical/pharma file to support regulatory submissions;• Technical support (researches, complaints, questions from the field or regulatory authorities). Show less DORC is a world leader in offering innovative medical devices for ophthalmic surgeries with subsidiaries and distributors all around the globe.As QA Officer my main tasks are related to maintaining , improving and establishing QMS to assure continuously ISO certification, products CE marking and FDA (among others) requirements to be fulfilled.Acting as a QA representative at all medical devices productions areas: instruments, electro medical equipments (including active) and clean room operations.Supporting the control over process and products deviations and complaints guaranteeing continuous improvement and compliance. Show less
Senior Project Manager
Jan 2019 - Nov 2019QA Officer
Apr 2017 - Jan 2019

Philips
Nov 2019 - nowManaging Correction & Removals (recalls), Complaint Handling and Adverse Events reporting for International Markets. Leading the performance of the Western Europe team for reporting of those activities with EU Competent Authorities. Managing medical devices field changes/recalls/corrections & removals on a regulatory role from announcement to termination. Point of contact for markets and competent authorities. Responsible for Health Hazard Evaluation among other Q&R deliverables. Ensures patient/user safety is number one priority for the business.
Sr. Post-Market Surveillance Manager
Apr 2022 - nowField Action Manager
Nov 2019 - Apr 2022
Licenses & Certifications

Internal Auditor ISO 19011
EBC
ISO 13485
DNV GL
Lean Six Sigma Black Belt
Voitto Treinamento e DesenvolvimentoDec 2016
Agile + Scrum
Agile Scrum GroupJul 2019
Project Management + MS Project
Ietec - Instituto de Educação TecnológicaJan 2017
Languages
- enEnglish
- spSpanish
- poPortuguese
- duDutch
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