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Alicia Riesgo

Regional Compliance Manager

Compliance Expert

Areas of Expertise

  • CQV Project Management
  • Project and Validation Master Planning
  • Facilities/Utilities/Equipment Start-up, Commissioning and Qualification
  • Risk Assessment
  • Quality Assurance/Regulatory Compliance
  • Lean CQV practices – ASTM E2500 implementation
  • Validation Training
  • System Turnover
  • CQV Consultancy

 

Industry continuous process improvement, technology innovations and increased regulatory expectations creates opportunities for companies to deliver a high quality and safer product to improve quality of life. Helping our clients to obtain their goals and be part of that process is exciting.

- Alicia Riesgo
Regional Compliance Manager

Alicia has over 20 years of progressive commissioning, qualification and validation project management experience in the pharmaceutical, biotechnology and life sciences industry.  She is a dedicated and customer-focused project manager with strong cGMP and regulatory knowledge with extensive experience in the execution of international CQV projects.

Her primary responsibility is to provide senior level project management and leadership for large and technically complex projects to help achieve project and client business goals.  Her experience in the area of CQV project delivery includes project management, master planning, and project cost/schedule development/tracking, risk assessment, FAT/SAT assistance, commissioning, qualification, validation, training, system turnover/documentation and interfacing with project team members.

Alicia collaborated with the University of Puerto Rico (UPR) and taught the Validation Course at the UPR Humacao Campus as part of the Biotechnology certification program.
 

  • p. 888.366.7660

Recent Projects

  • Biopharmaceutical Fill Finish Facility VMP  and CQV program development
  • Vaccine Manufacturing Facility C&Q Project Management/Execution
  • GxP Laboratory Relocation Validation Project Management
  • GMP Facilities Equipment Decommissioning Project Planning & Management
  • ADT Expansion Facility/Utilities Commissioning
  • BAS Panel Replacement Qualification Project Management