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Work Background
MI/PV QA MANAGER
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.
GVP AUDITOR
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
Quality Assurance Manager
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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QA Management for Life Sciences & Call Centers
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