* Conduct audits to ensure compliance with GMP, ISO, and applicable standards.* Designing and improving production systems.* Regulatory compliance.* Provide support to teams for quality system design, audits, and compliance.* Implement process excellence standards in daily quality operations.* Address and resolve product and process complaints related to suppliers.* Lead quality system audits to assess compliance.* Implement measurement systems to monitor quality and reliability effectiveness.* Develop and manage supplier quality agreements.* Management and implementation of continuous improvement tools.

* Cost reduction, elimination of waste of resources through effective monitoring, improved controls and optimized processes with the implementation of Lean principles.* Meet customer demands by monitoring market changes and adapting strategies.* Effective decision making based on detailed reports on daily operations (implementation of KPI's, financial, HR, Sales, Operations)* Strategies planned and executed to increase business and drive profit growth.* Train and guide area supervisors to improve the effectiveness and application of policies and procedures in order to achieve greater job satisfaction for employees and higher levels of performance.* Implementation of strategies for the expansion of the organization to boost the business and adapt to market changes.* Develop key operational initiatives to drive and sustain substantial business growth.* Work with department managers to keep up with needs and provide high-level support for day-to-day operations.* Cultivate an innovative, inclusive and performance-oriented business culture of areas to lead the industry and drive the progress of the organization.

* Coordination and execution of validation processes (IQ, OQ, PQ).* Responsible of implement a validation methodology to allow the optimization and robustness processes and / or equipment through design of experiment and variation transmission analysis, * Prepare and manage the master validation plan for each year and maintain the plant master validation plan records.* Support process and product validations (IQ, ETE, OQ, PQ) determining statistically valid sampling, analyzing validation data.* Support in test method validations using Gage R&R, and similar statistical techniques to ensure proper repeatability and reliability of test methods.* Support Engineering, Manufacturing and Quality personnel with R&R, DOE and VTA study.* Perform root cause analysis using analytical and problem solving skills - root-cause analysis.

* Provide oversight for the development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies* Perform quality of services conform to established internal and external standards and guidelines.* Work directly with operating entities and provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.* Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors.* Ensures the quality assurance programs.

* Compose SOP's, Visual aids, PFMEA's* Validation protocol development (IQ, OQ, PQ)* Process Characterization (DOE)* Experience leading CAPA projects.* Process transfer projects.* Process validation, product and machinery.* Make improvements activities to production systems (line efficiencies, quality indicators).* Perform analysis methods and times processes.* Material analysis perform.* Kaizen Events.

* Compose SOP's, Visual aids, PFMEA's* Deployment of packaging excellence projects.* Participates in process transfer projects.* Process validation, product and machinery.* Make improvements activities to production systems (line efficiencies, quality indicators).* Perform analysis methods and times processes.* Material analysis perform.* Kaizen Events.

* Documentation and improvements to manufacturing processes, optimizing performance within regulatory requirements.* Implementation of cost reduction projects.* Updating and creation of production lines / cells.* Design and implementation of fixtures / tools to facilitate operations.

Control Charts implementation (SPC)Coordinate Root Cause AnalysisPFMEA’s MSA StudiesNew Product IntroductionLine BalancingTime and movements studyAPQP/PPAP Knowledge