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Work Background
ProPharma GroupMI/PV QA MANAGER
Apr. 2023 - Oct. 2024United States, West Palm Beach•Assists in the planning of QA team audits
• Provides guidance to stakeholders on GVP compliance matters
• Oversees PV-related deviations, quality issues, CAPA, effectiveness checks, and root cause analysis
• Enhances the tracking and closure of Quality Systems, and minimizes errors through the use of advanced computer skills
• Works closely with management to devise effective strategies for addressing significant quality issues
• Examines problems, proposes corrective actions, and improves outcomes
• Formulates quality control procedures for inclusion in technical staff manuals
• Establishes a Deviation and Accreditation Certification Program
• Fosters a culture of empathy and quality-oriented thinking among peers and team members
• Conducts PV training for professional staff
• Evaluates GxP documents for compliance
• Engages with clients during monthly and quarterly meetings
• Facilitates audits to support the QA team.
PQE GroupGVP AUDITOR
May. 2022 - Apr. 2023United States, West Palm BeachPerforms PV QA audits of the PV System (activities, critical processes, vendors, etc.) and of the PV QMS
• Advises stakeholders on GVP Compliance Issues
• Manages PV related Deviations, Quality Issues, CAPA, Effectiveness Checks, and Root Cause Analysis
Pleio IncQuality Assurance Manager
Apr. 2015 - Jan. 2021United States, Hollywood
• Developed Standard Operating Procedures (SOPs) and comprehensive training guides for projects that required coordination across multiple departments.
• Identified key performance indicators (KPIs) and introduced preventive and corrective measures to address the root causes of quality issues and delivery delays.
• Formulated processes, policies, and procedures for various areas within the department, leading to the seamless integration of production and quality assurance processes.
• Designed workflows, crafted manual test scripts, and developed comprehensive testing plans and strategies.
• Oversaw Quality System compliance and management, ensuring all standards were met.
• Authored detailed reports and papers, and organized supporting documentation for easy reference.
• Offered strategic regulatory advice to both internal and external stakeholders, ensuring compliance with FDA regulations.
• Regularly reviewed the organization's internal practices to ensure adherence to government regulations.
• Designed and implemented an audit program capable of identifying potential risks and assessing compliance requirements.
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