Jorge López Fernández Email & Phone Number

During my time as QC Finished Product Technician at Reig Jofre, I have been able to develop certain competences which I keep improving on a daily basis:Daily management in the QC laboratory: Organization of analysts belonging to the physicochemical section of the QC laboratory ito optimize their work guaranteeing the on-time release of manufactured products from several production lines. Review of physicochemical analysis which are defined in the finished product specification (Assay and Related Substances (UHPLC/HPLC), pH, Water Content using Karl-Fischer method, IR Identification, etc.) of both oral (tablets, capsules, powders for oral suspension, sachets and syrups) and sterile products (vials).EMPOWER 3 FR5 system: Data acquisition and processing, along electronic review of processed results. Creation of suitable Method Sets, Instrument Methods, Report Methods and Processing Methods for each analytical method.Analytical problem resolution in the QC laboratory.Leadership and involvement in OOS investigations. Guarantee of the investigation’s compliance within the defined due dates and establishment of corrective/preventive actions against the root cause found.Participation in root cause investigations of deviations detected in the QC department and in other deviations in which QC might be involved.Incident management within the QC laboratory: Register, classification and resolution.Use of Navision ERP system employed to manage the main processes developed at the company, emphasizing the use of the QC module.Creation of sampling plans for each product code manufactured at Toledo’s Factory, taking into account the necessary amount of samples for physicochemical analysis, microbiology analysis and for the sample library, guaranteeing the compliance with the specific procedures.Review and management of sample library finished product unities, guaranteeing its compliance within the defined specifications.MyQumas EQMS system employed for the creation, administration and updating of GxP documentation.Updating of QC documentation to guarantee it does not exceed its expiry date.TrackWise software for the management of the quality system: Creation and management of OOS and deviation investigations, change control creation and closure and also creation and establishment of corrective/preventive actions (CAPAs) against root causes or to avoid recurrences.Audit experience: Ensuring audit readiness in laboratory, subject preparation and presentation during external and internal audits.