Quality Systems Management. Responsible for the management of Quality Deviations, CAPA, Change Control, Quality Documentation (Quality Manual, Policies, SOP's), Training, Consumer Complaints, Product Release, Audits and Inspections. Total 17 FTE.

- Project Management for small and medium projects, including resources management (budget, CAPEX);- Implementation of Lean Six Sigma projects for administrative areas (office);- Computer Systems Validation (Control Systems & Analytical Equipment);- Pharmaceutical Process Validation & Cleaning Validation- Quality Tools - Deviation, Change Control, CAPA, Risk Analysis, Root Cause Analysis

- Lean Six Sigma Projects - Management of a project for Finished Goods Analysis Lead Time Reduction, with savings > 30% in lead time using Lean and Six Sigma tools. Participation in a Kaizen to reduce backlog of Stability Analysis, through the use of Lean Tools and Management;- Project Implementation - Coordination of project teams; time and costs management. Deployment of Computer System (Empower) locally as part of a global implementation.- Computer System Validation (CSV) - CSV Master Plan (GAMP 5), User Requirements Specifications, Qualification (IQ, OQ, PQ) Protocols and Reports, System Inventory, Risk Analysis; Validation of Building Management System (Apogee Insight), Laboratory Information Management System (Labware LIMS) and Chromatography Data System (Empower);- Cleaning Validation - Cleaning Validation Strategy, Protocols and Reports; Worst Case Definition and Limits Calculation (based on Excel macros), Sampling Plans, Cleaning Procedures, Detergent Studies;- Process Validation - Process Validation Protocols and Reports, Statistical Analysis (Minitab), Sampling Plans (Military Standard) for Cream, Ointments, Lotions and Shampoos, Continued Process Verification;- Cold Chain Validation - Cold Chain (2ºC to 8ºC) Validation Protocols and Reports; Packaging and Ice Development Studies;- Equipment Qualification - Equipment Qualification Protocols and Reports (IQ, OQ, PQ) for tanks, fillers, packaging machines, stability and cold chambers, HPLC's;- Quality Tools - Deviation, Change Control, CAPA, Risk Analysis, Root Cause Analysis

Validation of Stiefel Global LIMS: Brazil, United States, England and Ireland (including travels to these countries); creation of validation master plan, user requirements specifications, test scripts and traceability matrices; revision of change controls, functional specifications, procedure manuals; execution of test scripts, analysis validation; creation and revision of specifications and analyses.Member of Stiefel Global CSV Committee for the roll out of Global Policies and Procedures;Validation - Creation, revision and execution of Cleaning Validation and Process Validation Protocols and Reports;Creation of Standard Operational Procedures and Training;

Creation, revision and execution of Validation Master Plan and Procedures;Process Validation - Creation, revision and execution of Process Validation Protocols and Reports, Statistical Analysis, Sampling Plans;

Computer System Validation - Validation of ThermoLabs Atlas Chromatographic Data System