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Melissa Echeverria
Independent Contractor @SGS
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WORK HISTORY
Independent Contractor @SGS
US
Performed third-party Pharma, Cosmetics, and Personal Care (PCPC) audits per SGS Certification procedures and the requirements of the applicable standards. Responsible to make relevant decisions regarding the audit process and informs SGS CBE on issues resolution outside the audit process. Collected and analyzed sufficient information to provide a recommendation for certification and had the authority for the control and performance of auditing activities, including planning and control of other members of audit teams.• Qualified as a Lead Auditor in more than one standard (i.e. ISO 22716, EU GMP, WHO GMP/GDP, EFfCI and EXCIPACT, ISO 15378, ISO 9001, etc.) and conducted integrated audits where required as per SSC global procedures, local procedures, guidance and instructing of Technical Manager.• Performed certification audits in any capacity in conformance with the SGS Global/Local procedures, sector specific schemes/standards and ensured that such duties are performed in an efficient and commercially expedient way.• Provided determination whether or not registration should be recommended or allowed to continue.
EDUCATION
University of Phoenix
Master of Business Administration, Management
New Jersey City University
Baccalaureate of Science, Biology
ABOUT MELISSA ECHEVERRIA
QUALITY MANAGER/DIRECTOR - A proven advocate for results driven Quality Management Systems with 14+ years of Quality Assurance experience demonstrated to exceed expectations. Experienced in establishing company quality management systems, fostering growth, while remaining cognitive of the bottom line. Committed to upholding integrity for internal and external stakeholders. Strong interpersonal skills; highly effective at using leadership, organizational and communication skills to develop productive teams, as well as maintain relationships with vendors and clients. In-depth understanding of CGMP /GDP regulations (US, EU, Swissmedic, Health Canada, MAPA, SENASICA, APVMA, ICH, WHO, and Japan) and quality systems including Deviation, CAPA, OOS, Change Control, Document Control, Testing Review and Release, Testing Review and Release, and Supplier Quality.Specialties: development/implementation of quality management systems, training programs, audit programs, supplier quality management, GxP compliance audits, domestic and international regulatory compliance, inspection readiness, and source document quality reviews for regulatory submissions.Product breadth of experience includes: pharmaceuticals (solid dosage, ophthalmology, and topical ointments), Animal health (ophthalmology, medicated feed additives, adjuvants, and vaccines)Biotechnology( Human Biological Samples, Cell Therapy, advanced therapy medicinal products (ATMPs)), biopharmaceuticals (radioligand therapies), food, and cosmetics.
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