Marylu Pino, PhD, MBA

Implementation of GMPs and GLPs. Remote operation monitoring at each site. Technical support in water system for industrial processes with purified water. Alignment to local, international regulatory requirements, standards, quality agreements, guidance documents, pharmacopoeias and ISO standards (ISO 9001,17025,14001) and OSHA 18001. Experienced with ANMAT, INVIMA, ANVISA, FDA. Risk Analysis, with a preventive focus, based on strategic audits and remediation with specific action plans. HACCP implementation. Process validations. Continuous improvement through PDCA. Resolution of complex quality problems in manufacturing processes. Implementation of quality management systems (QMS), monitoring, process control and PDCA. Change Management. Customer complaints remediation plans.Review and implementation of product specifications. Technical review of designs for sanitary manufacturing of engineering projects (pharmaceuticals, cosmetics, food). Automation and Scaling Up of processes. Documentation Management and follow-up of GMP audit and CAPA plans. Management of Non-Conformities. Internal auditor and external audits to suppliers and 3PL - report and remediation with action plan and follow-up. Review and approval of manufacturing and general procedures. Product Development Projects and Formulations. Management of Microbiology Laboratories and application of GLPs - USP 1117, ISO 17025 (sterile products, pharma, medical devices, cosmetics, food). Clinical and environmental microbiology (Expertise in quality training that seeks to generate a true culture of quality. Expertise in transferring laboratory methodologies (microbiology, physicochemical, quality, molecular).