Alex Ramos

About Alex Ramos

Seasoned Quality Assurance & Validation Professional with extensive experience in biotechnology, pharmaceutical, and medical device industries. Specializes in Quality Systems, Validation, and Regulatory Compliance, having led high-impact projects across startups, technology transfers, plant remediations, and facility expansions.Expert in FDA, GMP, 21 CFR Part 11, GAMP 5, and Data Integrity requirements, ensuring compliance with industry regulations while optimizing efficiency and mitigating risks. Recognized for providing strategic oversight in validation planning, quality audits, and regulatory inspections, collaborating with cross-functional teams to drive operational excellence.Key Expertise & Achievements: VALIDATION & QUALITY SYSTEMS: Managed validation programs from inception, including Commissioning & Qualification (CQV), Risk Assessments, Computer Systems Validation (CSV), Process Controls, and Equipment Qualification (IQ/OQ/PQ). FDA COMPLIANCE & AUDIT READINESS: Direct experience in FDA inspections, remediation plans, and warning letter responses, ensuring regulatory adherence across all operations. Implemented audit strategies and CAPA initiatives to strengthen compliance. DATA INTEGRITY & COMPUTER SYSTEM VALIDATION (CSV): Led SDLC documentation, periodic reviews, data integrity assessments, and decommissioning projects, ensuring system security and regulatory compliance. Expertise in Veeva Vault, Manufacturing Execution Systems (MES), Learning Management Systems, and ALCOA principles. CROSS-FUNCTIONAL LEADERSHIP: Led multi-site validation teams across the U.S. and Puerto Rico, training 100+ employees in GMP, validation best practices, and regulatory compliance. Developed SOPs, Change Control programs, and Quality Metrics dashboards to enhance efficiency. HIGH-IMPACT INDUSTRY PROJECTS: Played a critical role in new plant startups, equipment and utility qualifications, technology transfers, and remediation projects for operations under FDA oversight. Key contributor in zero-observation audits across multiple projects.

Experience

1. Senior Quality Assurance Consultant

   CooperSurgical

   Jun 2023 — Present

Education

• University of Puerto Rico

  Bachelor, Chemical Engineering

Skills

• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Iso 13485
• Verification and Validation (V&V)
• Glassware
• Capa
• Fmea
• Computer System Validation
• Sop
• Fda
• Validation
• Quality System
• V&V
• Project Management
• Software Documentation
• Gxp
• Equipment Qualification
• Maximo
• Change Control
• Gmp
• 21 Cfr Part 11
• Lims
• Quality Assurance
• Standard Operating Procedure (Sop)
• Trackwise