Personal Information
Organization / Workplace
Puerto Rico area Puerto Rico
Occupation
Senior Regulatory Affairs Specialist
Industry
Medical / Health Care / Pharmaceuticals
About
Experience at Biotechnology, Pharmaceuticals and Medical Devices manufacturing, technical, validation, regulatory and quality assurance areas. BSI Certified - RABQSA ISO 13485:2003 Lead Auditor (TPECS). Experience in project management, procedures & batch record development and design, quality audits, non-conformance investigations, and corrective actions definition and implementation, SOP’s and cGMP’s development and training. Fully bilingual, willing to work under pressure and with minimum supervision; liaison / teamwork oriented with excellent organizational and negotiation skills, committed and focused to results
Contact Details
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