Fabiola Rivas
Summary
Developed critical problem-solving and analytical skills in a rigorous regulated environment, consistently ensuring high quality and compliance standards. Expertise in validation processes and data analysis, adaptable to various industries and roles. Seeking to leverage these transferrable skills in a new and challenging field.
Overview
28
28
years of professional experience
Work History
Quality Assurance/Validation Engineer
Ortec Inc. Chemicals
09.2022 - 10.2024
- Managed, reviewed, approved, and controlled company documents following standard operating procedures (SOP) and work instructions
- Supported the validation program by creating and reviewing qualification and validation protocols (IQ, OQ, PQ) and their corresponding reports
- Ensured client approval for contracted validation projects and their associated reports
- Created, reviewed, and approved engineering change requests (ECRs)
- Assisted in defining and implementing maintenance and calibration programs for equipment used in Good Manufacturing Practices
- Assisted with FDA, third-party, and customer audits
- Contributed to the vendor qualification and disqualification program
- Identified deviations and tracked them to completion
- Conducted weekly facility safety checks
Operation Support / Project Manager
PL Developments Inc.
01.2018 - 01.2022
- Collaborated with the engineering team to identify equipment and processes for new business production lines
- Initiated the Change Control Notice (CRN) for manufacturing equipment (induction, relocation, modification, and decommissioning)
- Coordinated the qualification and requalification of GMP equipment for manufacturing activities with the Validation Department
- Collaborated with the Maintenance Department to schedule and monitor the maintenance and calibration of manufacturing equipment
- Supported Operations Management and the Quality Unit in following up and closing CRNs, deviation investigations, and CAPAs related to equipment and materials
- Assisted during internal and external audits and inspections
- Conducted training for Operations Department team members
- Promoted process improvement
- Adhered to and promoted company safety guidelines
- Maintained compliance with SOPs, current Good Manufacturing Practices (cGMP), and regulatory guidelines
Document Control Specialist
PL Developments Inc.
01.2018 - 01.2020
- Maintained and managed electronic and paper-based record systems (issuance, intake, storage, and retention of company-controlled documents)
- Maintained offsite records storage and organization
- Supported the transition to electronic document management systems
- Ensured compliance with established document control and retention procedures
- Worked with multiple departments to ensure document accuracy and improvement by addressing comments and corrections
- Supported internal and external audit activities, including FDA inspections and ISO certification
- Created, reviewed, and approved standard operating procedures (SOPs) as applicable
- Performed administrative tasks as required
Validation Project Manager
Piramal Pharma Solutions Inc.
01.2014 - 01.2018
- Coordinated activities with other departments to ensure successful project execution
- Developed validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and summary reports
- Reviewed validation protocols and revised master templates to reflect current processes and requirements
- Scheduled and facilitated meetings with vendors and the team
- Requested materials from the warehouse and equipment from Operations to complete validation studies
- Ensured that the validation equipment was calibrated
- Maintained monthly reports for the requested validation documents
- Tracked department progress for the timely closure of projects
- Trained employees on the validation documentation requirements and the proper use of validation equipment
- Reviewed Operations SOPs for conformance with validated equipment, processes, and load configurations
- Authored and reviewed SOPs for the Validation Department
Material Management Associate
Piramal Pharma Solutions Inc.
01.2012 - 01.2014
- Planned the efficient movement of goods in compliance with company policies and procedures
- Ensured quality assurance and quality control for all incoming products and materials
- Managed and restocked inventory
- Issued materials
- Prepared control material reports
- Created inventory control forms
- Authored and reviewed standard operating procedures (SOPs)
Administrative Assistant
Petróleos de Venezuela, S.A.
01.1997 - 01.2010
- Relocated to the United States in2010
Education
No Degree - English Language
University of Kentucky
Lexington, KY12-2012
Bachelor of Science - Business Administration
Universidad Dr. Rafael Belloso Chasin
01.1996
Associate in Business Administration - undefined
CUNIBE
01.1992
Skills
- Project Management
- Stakeholder Engagement
- Document Management
- Procurement Management
- Regulatory & Compliance Program
- Technical Writing
- Training
- Strong organizational and critical thinking skills
- Microsoft Office (Word, Excel, PowerPoint, Teams for Business, and Outlook)
- Oracle – Database Management System
- Agile - Document Management Software
- ETQ Reliance Application: Document Control
- DocuWare - Document Management and Workflow Automation Software
- D365 – Business Application
- Asset Essentials - CMMS
- Manager Plus – CMMS
Languages
Bilingual in English and Spanish.
Accomplishments
Recognized with a company award for exemplary teamwork and the ability to make a positive impact on others.
Timeline
Quality Assurance/Validation Engineer
Ortec Inc. Chemicals
09.2022 - 10.2024
Operation Support / Project Manager
PL Developments Inc.
01.2018 - 01.2022
Document Control Specialist
PL Developments Inc.
01.2018 - 01.2020
Validation Project Manager
Piramal Pharma Solutions Inc.
01.2014 - 01.2018
Material Management Associate
Piramal Pharma Solutions Inc.
01.2012 - 01.2014
Administrative Assistant
Petróleos de Venezuela, S.A.
01.1997 - 01.2010
Associate in Business Administration - undefined
CUNIBE
No Degree - English Language
University of Kentucky
Bachelor of Science - Business Administration
Universidad Dr. Rafael Belloso Chasin
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