Marco Pulcini

Marco Pulcini Email and Phone Number

Diretor-Gerente da Qualidade e Assuntos Regulatórios @ Pinex
São Paulo, Brazil
Marco Pulcini's Location
São Paulo, Brazil, Brazil
Marco Pulcini's Contact Details

Marco Pulcini personal email

n/a
About Marco Pulcini

Healthcare professional with 15 years of experience in Quality and Regulatory with a focus on Compliance in Supply Chain. Trilingual, fluent in English, Spanish and Portuguese.Excellent presenter. Comprehensive background includes successful work and leadership in the local, regional and global Supply Chain network of internal and external sites in key quality pillars such as Quality Systems, Quality Assurance, Quality Control, Medical/Clinical Supplies, Supplier Quality and Audits. Always pursuing the highest standards of quality, ethics, compliance, efficiency and ethics through strategic leadership with a focus on customer and consumer satisfaction and business needs. BSc in Biomedical Sciences, postgraduate degrees in Toxicology and Quality Control.Overall responsibilities and portfolio of achievements include remediation and sustainability of the quality and compliance profile in the sites covered by the QMS, including commercial offices, distribution centers and suppliers and distributors partners, attending enterprise and health authority expectations. Remarkable results in audits and supplier assessment program, readiness for audits and inspections. Significant performance at Pinex, J&J and DHL employers. Implemented intensive internal training for auditors that saved 20K in 2023 replacing external training.Conducted on-site audits at more than 60 carriers per year at transportation service providers. Supervised internal audits, 15 sites at J&J and 7 sites at DHL. Led the Purchasing Controls Process for GxP suppliers and distributors: J&J over than 600 suppliers/180 distributors; DHL 100 suppliers.Expert in regulations for the import, storage, distribution and transport of products. For Brazil it includes ANVISA, INMETRO, IBAMA (environmental), CETESB (environmental), Fire Department regulations (AVCB) and IATA/ANAC/ANTT dangerous goods regulations.Helped orchestrate projects for business acquisitions and divestitures, product launches, field actions, recalls and discontinuations. Site commissioning and decommissioning.Deep interaction with the areas of Quality, Regulatory Affairs, Technical Services, Copy Review, Marketing, Logistics, Warehousing and Transport, Facilities, Maintenance and EHS.Experience supporting the Pharmaceuticals, Medical Devices, Consumer Goods, Nutraceuticals and Sanitizers business segments. Expertise in the areas of Logistics, Supply Chain, 3PL, Import, Distribution, Warehousing, Transport, Wholesale, Clinical Laboratory, Higher Education, Hospital and Home Care Nursing.

Marco Pulcini's Current Company Details
Pinex

Pinex

View
Diretor-Gerente da Qualidade e Assuntos Regulatórios
São Paulo, Brazil
Website:
pinex.com.br
Employees:
131
Marco Pulcini Work Experience Details
  • Pinex
    Diretor-Gerente Da Qualidade E Assuntos Regulatórios
    Pinex
    São Paulo, Brazil
  • Pinex
    Director Of Quality And Regulatory Affairs
    Pinex Sep 2023 - Present
    Brazil
  • Johnson & Johnson
    Quality Supervisor
    Johnson & Johnson Oct 2018 - Sep 2023
    Brazil
  • Johnson & Johnson
    Senior Compliance Analyst
    Johnson & Johnson Jan 2015 - Oct 2018
    Brazil
  • Dhl
    Senior Regulatory Affairs Analyst
    Dhl Jan 2012 - Dec 2014
    Brazil
  • Line Life Cardiovascular
    Quality Specialist
    Line Life Cardiovascular Jan 2010 - Jan 2012
    São Paulo, Brazil
  • Dasa
    Microbiologist
    Dasa Jan 2006 - Jan 2010
    Barueri, São Paulo, Brazil
  • Unilus - Centro Universitário Lusíada
    Microbiology Lab Supervisor
    Unilus - Centro Universitário Lusíada Jan 2005 - Jan 2006
    Santos, São Paulo, Brazil
  • Prefeitura Municipal De Santos
    Molecular Biology Laboratory Intern (Craids)
    Prefeitura Municipal De Santos Jan 2003 - Dec 2004
    Santos, São Paulo, Brazil
  • Nursing Assistant
    Certified Nursing Assistant
    Nursing Assistant 1999 - 2004
  • Brazilian Army (Exército Brasileiro)
    Military Service
    Brazilian Army (Exército Brasileiro) Jan 1999 - Dec 1999

Marco Pulcini Skills

Regulatory Affairs Quality Assurance Gmp Medical Devices Quality System Pharmaceutical Industry Microsoft Excel Microsoft Word Product Development Biotechnology Regulatory Submissions Microsoft Office Lifesciences Fda Powerpoint Anvisa Visa 5s Iso Iso 9000 Iso 13485 Iso 9001 Logistics Supply Chain English Spanish Portuguese Brazilian Portuguese Espanhol Windows Wholesale Class Iii Medical Devices Medical Device Pdca Kaizen Business Strategy Business Planning Strategic Planning Quality Control Sop Auditing Compliance Life Sciences

Marco Pulcini Education Details

Frequently Asked Questions about Marco Pulcini

What company does Marco Pulcini work for?

Marco Pulcini works for Pinex

What is Marco Pulcini's role at the current company?

Marco Pulcini's current role is Diretor-Gerente da Qualidade e Assuntos Regulatórios.

What is Marco Pulcini's email address?

Marco Pulcini's email address is ma****@****.com.br

What schools did Marco Pulcini attend?

Marco Pulcini attended Fiocruz - Fundação Oswaldo Cruz, Universidade Santo Amaro - Unisa, Unilus - Centro Universitário Lusíada, Enfesp - Enfermagem Especializada | Nursing School.

What skills is Marco Pulcini known for?

Marco Pulcini has skills like Regulatory Affairs, Quality Assurance, Gmp, Medical Devices, Quality System, Pharmaceutical Industry, Microsoft Excel, Microsoft Word, Product Development, Biotechnology, Regulatory Submissions, Microsoft Office.

Who are Marco Pulcini's colleagues?

Marco Pulcini's colleagues are Daise Almeida, Aline Soares, Karyn Namie Dos Santos, Maria Luiza Martinez Costa, Japa Souza, Thiago Da Mota Gomes, Maria Oliveira.

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