Description
PROFESSIONAL SUMMARY QUALIFICATIONS ASQ member, CAPA Expert Certified, CQA, Quality Risk Management - FMEA, Introduction and Internal Auditor for ISO 9001. Knowledge in cGMP Regulations and International Standard (ISO) as 21CFR820, ISO 13485, 21CFR210 & 211, ISO 9001 & ISO 14001. OSHA Rules, Quality Assurance & Control, Manufacturing, Production, Warehouse, Pest Control. Computer skills: Trackwise, SAP, Maximo, LIMS, Visio, Minitab, Auto Cad and Microsoft Office. Interpersonal Skills, Bilingual (Spanish / English), Self-starter & Team player, Customer Service Oriented, Analytical Thinking & Problem Solving. Innovative and Visionary. Willing to travel and relocate. Process Control and Computer System Validation. Develop and update Training for cGood Manufacturing & Documentation Practices. Bring interactive classroom training for cGMP's, cGDP's. Maintain Trainings Module and hard copy records ready for inspections. Identify training gaps and address with appropriate departments. Provide GMP & GDP guidance to facility personnel. Monitor the training program and ensure training gaps are addressed. Coordinate and perform training records internal audits. Create checklist and audit plan per area using applicable regulations 21CFRPart820 ISO13485 and internal procedures requirements. Document nonconformities and discuss with responsible management. Write audit results report and presented to responsible management. Manage regulatory inspections quality systems audits such CAPA and root cause analysis to ensure compliance. Performs Quality Management System internal audits and reports give observations follow up. Participate in regulatory and corporate inspections. Perform CAPA effectiveness verification. Improve the Quality Management System and implement changes. Revise Quality System procedures to address compliance gaps. Lead Parexel Regulatory Audit as Back Room Request Review.
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