Paula Marques Email
Associada @ Harpio
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Paula Marques Location
- São Paulo, SP, BR
Paula Marques Work
- Associada @ (February 2025 - Present)
- Co-Founder and Scientific Director @ MD Health Science Consulting (January 2022 - Present)
- Vice President and volunteer member @ (December 2021 - Present)
- Independent Consultant Pharmaceutical Sciences @ RHHA - Consultoria Empresarial (June 2020 - February 2025)
- VP REGULATORY AFFAIRS LACAN (Latin America and Canada) @ (September 2016 - May 2020)
- HEAD OF REGULATORY AFFAIRS Brazil and Latin America @ (October 2007 - August 2016)
- HEAD OF MANUFACTURING OPERATIONS @ (December 2003 - September 2007)
- HEAD OF QA and PHARMACEUTICAL TECHNOLOGY @ (March 1996 - November 2003)
- R and D Supervisor @ HMR (SANOFI AVENTIS) (February 1990 - March 1996)
- Validation Specialist @ Syntex Pharmaceuticals (February 1986 - February 1990)
Paula Marques Education
- BSP (Business School São Paulo)
Master on Business Administration (Project Management)
2004-2005 - Pós Graduação - Faculdades Oswaldo Cruz
Pharmaceutical Industry
1986-1987 - Pós Graduação - Faculdades Oswaldo Cruz
Pharmaceutical Sciences
1982-1986
Paula Marques Skills
- 21 CFR Part 11
- Biotechnology
- CAPA
- Change Control
- Clinical Trials
- Corrective and Preventive Action (CAPA)
- FDA
- GMP
- Good Manufacturing Practice (GMP)
- Manufacturing
- Market Access
- Medical Devices
- Pharmaceutical Industry
- Pharmaceutics
- Pharmacovigilance
- Product Development
- Product Launch
- Quality Assurance
- Quality Control
- Quality System
- R&D
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Research and Development (R&D)
- SOP
- Standard Operating Procedure (SOP)
- Strategy
- Technology Transfer
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- V&V
- Validation
- Verification and Validation (V&V)
Paula Marques Summary
- Paula Marques, based in São Paulo, SP, BR, is currently a Associada at Harpio. Paula Marques brings experience from previous roles at MD Health Science Consulting, FAPEPE-UNIESP, RHHA - Consultoria Empresarial and Allergan. Paula Marques holds a 2004 - 2005 Master on Business Administration in Project Management @ BSP (Business School São Paulo). With a robust skill set that includes 21 CFR Part 11, Biotechnology, CAPA, Change Control, Clinical Trials and more.
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