Raquel Buitrón C. Email & Phone Number

Madrid

-Serve as Quality Liaison between the EP/ExP and Organon; assure that the EPoperates within established policies and procedures and complies with allapplicable governmental regulations (GMP, etc.), both domestic and foreign.- Provide support to the EP/ExP to facilitate and validate new productintroductions and/or transfers.- Assist with and/or lead the development, and ongoing execution of the QualityAgreement with the EP/ExP and act as the Quality expert on Organon's behalfregarding contractual negotiations.- Leverage measures/metrics to provide on-going supplier performancemanagement (KPI, trend analysis, etc.).- Ensure inspection readiness of the EP/ExP and participate in regulatory andother quality and compliance report- outs; review audit outcomes to ensureappropriate and timely corrective actions are implemented (where warranted).- Maintain knowledge of emerging regulatory intelligence and proactively ensureEP/ExP adherence to any changes in regulations (as appropriate).- Manage compliance issues promptly and perform risk assessments on criticalissues to prevent disruptions to supply (i.e. stock out situation) of the market.- Maintain regular onsite presence to build relationships and provide firsthandoversight and/or performance monitoring; based on risk.- Ensure that all deviations at external manufacturer/partners related to OrganonProducts are fully investigated; with any assigned actions effectivelyimplemented within the agreed time frame.- Provide direct oversight to strategic/complex deviations and/or complaints; leadsignificant investigations (including Fact Findings) and coordinate product recallsas needed.- Provide calibrated Quality oversight based on product type, capabilities, andquality and compliance performance of the EP/ExP.

Greater Madrid Metropolitan Area

- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of Organon and compliance with all governing regulations; review and approve changes to master batch records.- Manage routine and complex deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer.- Provide support for audits of EP/ExP by Organon and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted.- Oversee repackaging activities in the ExP/EP.- Conduct routine and solves complex analytical change requests and support process modification change controls.- Stability Program management, including review of stability reports, and Annual Product Review assembly.- Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.- Track and monitor operational and quality performance of the external manufacturer/partner an can work with supplier to develop CAPA plans.- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.- Support routine process validation; review and approve validation reports/tech transfer.- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

Madrid, Community Of Madrid, Spain

Project Manager for large scale and international biopharmaceutical projects for the design and construction of pharmaceutical plants.

Madrid, Community Of Madrid, Spain

Head of qualification, validation and suppliers department at Inmunotek manufacturing plants.

Limerick, Ireland

Operation readiness line 62.

Madrid Y Alrededores, España

Head of Consulting Department. Senior Consultant in Process Validation, Cleaning Validation, Equipment Qualification, Risk Assessment. GMP Auditor and Trainer. Statistical data analysis.Most relevant projects:- MSD AH, Spain (Spherion Project): Project manager for commissioning and qualification of new plant's utilities and facilites. April 2017 - December 2019.- CALIER, Spain: Project manager for commissioning and qualification of new plant's utilities and facilites. March 2017 - December 2017.Principal audits performed:- Himexpharm Corporation, sterile product plant GMP compliance, Vietnam.- Hanko Fermion plant audit for API, Finland.Most relevant presentations as speaker:- Barcelona University, IL3, November 2016. “Cross Contamination inmulti-product plant”.- Barcelona University, IL3, November 2016 “Cleaning Validation: how toupdate cleaning limits based on PDE”.- GMP XV Edition, Barcelona, December 2017. “Risk analysis and implementation strategy of ICH Q3D: Elemental impurities”.- Webinar, march 2019 “Modern Qualification: Effective cooperation between client and supplier”.- Webinar, June 2017 “Cleaning Validation: updated concepts and changes”.

Madrid Y Alrededores, España

Validation Engineer. Industrial Development Department: manufacturing process validation, cleaning validation, in charge of improvements of cleaning validations. Equipment qualification, in charge of qualifications of new packaging lines. Investigation of deviations in on-going process.Packaging Supervisor. Manufacturing Department (September 2014 - April 2015): manage of packaging area (25 people). Validation Specialist. Manufacturing Department (January- August 2014): manufacturing process validation, cleaning Validation, equipment qualification, investigation of deviations in on-going process.

Madrid Y Alrededores, España

Manufacturing, packaging and cleanning process validation, equipment qualification. In charge of Annual Product Quality Review. Technology Transfer Product Leader.

Madrid Y Alrededores, España

Quality Technician in charge of manage CAPAs, deviations, change controls and costumer complaints.

Madrid Y Alrededores, España

Quality technician in charge to perform in process controls, sampling, documentation review, and product release.

Engineer’S Degree, Bs/Msc, Cum Laude

Master’S Degree, Quality Managment