Manage, control and follow up the opening, investigation, classification, evaluation and closure of quality events, deviations and atypical results, out of specification and non compliance with AQL. Develop, review and evaluate risk analysis. Manage and follow up the Corrective Action / Preventive Action System (CAPAs). Provide support in the development of the Validation Master Plan including validations of computerized systems. Review and approve equipment qualifications, critical support systems water, air, HVAC. Review and approve qualification protocols and reports such as URS, DQ, IQ, OQ, PQ, Site Acceptance tests. Coordinate the collection, perform statistical analysis of data to prepare the annual Product Quality Review Report (PQR). Manage and support in the management of quality assurance KPIs.

In charge of elaborating and executing the Validation Master Plan. Coordinate validation activities with other areas. Perform protocols and reports of cleaning validations, aseptic filling of manufacturing processes, critical support systems: water, steam and compressed air. Elaborate protocols and reports of equipment qualification: DQ, IQ, OQ, PQ and URS of quality control area equipment, biological production, pharmaceutical production and warehouse. Use of Minitab software for validation data processing. Development and optimization of chemical formulations of veterinary pharmaceutical products such as oral solutions, syrups, topical solutions, injectables, cosmetics. Development of biological veterinary products: virus vaccines, bacteria for livestock, poultry, pets. Development of analytical methodologies for finished products, determination of linearity, repeatability, accuracy, range. Scaling of pilot batches from laboratory to manufacturing and commercial pilot. Dossiers of injectable products, cosmetics, pharmaceuticals, biological vaccines for national (ARCSA and AGROCALIDAD) and international entities. Uploading information to the system and making necessary corrections. Performing field tests of pharmaceutical and biological products. Managing indicators of the validation process.

Qualification of critical support systems: air, water and steam; manufacturing areas; production and laboratory equipment (automatic and manual vial and ampoule fillers, autoclaves, sampling booths). Validation of aseptic filling of vials and ampoules. Validation of manufacturing processes: Metronidazole, Ascorbic acid. Qualifications of design, installation, operation and performance of production equipment and quality control equipment. Lead analyst in developing and validating analytical methods in HPLC, UV-VIS, Titration and Microbiological methods. Developed and validated analytical methods under ANAMED and ANVISA standards.

Documentation analyst generating monthly indicators (KPI's, RFT) based on document review, double checks, inspections and internal audits. Collaborated with global QA department in QA programs, training manuals and quality guidelines. Ensured quality of drugs being transferred, scaled and developed met internal and external requirements. Analyzed development and transfer process of pharmaceutical products, identifying error-prone areas. Developed preformulations and final formulations of drugs such as syrups and creams, developed analytical methodologies in HPLC for active ingredients and preservatives, validation of analytical methods, stability analysis. Manufactured demo and pilot batches, manufacturing validation applying STATA for process capability. Assembled dossiers for regulatory bodies in Chile. Co-led drug development and transfer projects from Chile to Ecuador using project management tools. Reviewed and approved documentation.

Chemical stability analysis. Industrial scaling. Chemical, physical and microbiological analysis of raw materials, product in process and finished product. Determination of active ingredients with infrared spectrophotometer. Implementation of ISO 9001, GMP, PBL. Coordination of daily quality activities (analysis, reports, approvals). Reporting of SETED substances movement. Led standardization projects and GMP implementation. Managed a team of 2 people.

Same activities as previous period.

Development of new formulations and optimization of previous formulations. Testing of formulations on flowers and analysis of trials. Laboratory to plant scale-up. Stability analysis of formulations. Process standardization, implementation of ISO 9001, GMP, PBL. Coordination of daily quality activities (analysis, reports, approvals). Determination of quality indicators such as KPI, RFT (Right First Time). Led projects of optimization and improvement of processes and formulations through rheological studies, vase life testing and stability analysis. Managed a team of 3 people. Reduced mixing time by 40% for all Everflor products, improving efficiency and production capacity of the plant. Implementation of Good Manufacturing Practices (GMP).