Experienced Auditor, Technical writer and QA-QC Professional with 25 years of experience seeking a Pharmaceutical position by offering skills to manage, lead or participate on a short, medium or long-term projects within the FDA regulated industries on Documentation, Systems Set Up and Enhancements, Quality Control, Quality Assurance, ASRs-APRs Preparations and Reviews, Auditing, Method and Process Validation, Calibrations, Workflow Analysis and Efficiency Enhancement Projects with focused global environments. Well experienced with cGMP, FDA / ICH guidelines and OSHA regulations to support productivity, product quality and patient safety. Provide scientific and regulatory compliance consulting services to the pharmaceutical, OTC, and biotechnology industries.