INTEGRATED ENGINEERING : OPERATIONAL EXCELLENCE

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    • Home
    • Services
      • Program Mgmt
      • Operational Excellence
      • Technology Implementation
      • CQV-Process
      • CQV-Facilities/Utilities
      • Data Integrity Compliance
      • Shutdown Mgmt
      • NC/CAPA
      • Construction Mgmt
    • Projects
      • Manufacturing Technology
      • Site Development Projects
    • Core Team
      • José Colón Freyre
      • Maria Enid Rosa, PhD
    • About
      • Mission
      • Why Contract Us?
      • Testimonials
    • Contact Us
    • Insights
      • Blogs
      • YouTube Channel Link

info@profitsengineering.com


  • Home
  • Services
  • Projects
  • Core Team
  • About
  • Contact Us
  • Insights

PRINCIPAL- QUALITY CONTROL & QUALITY ASSURANCE

EXPERIENCE


With a PhD in Chemistry and over 20 years in the pharmaceutical industry directly implementing Quality Management Systems (QMS) and managing QC/QA, MER brings great expertise in QMS and balance to our Technical Services team.  


MER has developed complete Quality Management Systems in the pharma industry with hands-on expertise in: 

  • Data Integrity
  • Deviation Investigations
  • Corrective and Preventive Actions
  • Change Management
  • Analytical Test Method Development, Validation and Transfer
  • Laboratory Equipment Qualification, PM and Calibration
  • Application of Lean and Six Sigma tools in laboratory operations
  • Process Analytical Technology
  • Standard Operating Procedures
  • Analytical Laboratory Investigations
  • New Laboratory Facilities Design Management
  • Compendial Method Verification
  • Computer System Validation

 
Qualifications and Education:

  •  PhD in Chemistry

PhD in Chemistry and over 20 years in the pharmaceutical industry leading Quality and laboratories

 Maria Enid Rosa, PhD (MER) 


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PASSION FOR PROFITS. YOURS.

Announcement

 As the COVID-19 pandemic continues to evolve, we are committed to keeping our staff and their families safe. We are also committed to delivering superior results as efficiently as possible and have developed remote working capabilities as well as methods to be on-site safely.  CONTACT US, WE CAN HELP!

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