Andoni Montero Arratibel Email & Phone Number

Alcalá De Henares, Comunidad De Madrid, España

Madrid Y Alrededores

- Creation and review of GMP documentation such as SOPs and manufacturing masters.- Management of GMP training for the personell of the area.- Creation and management of CAPAs.- In charge of approving the start of the packaging process of the batches. - Planification ,according priorities, of the production batches.- On-site resolution of GMP non-compliances.- Preparation of internal and external audits.- Review of manufacturing and packaging records.- Adjustments in production equipments.

Madrid Y Alrededores, España

- Investigation and redaction of deviations / claims.- Creation and management of CAPAs.- Revision of SOPs.- Audits and inspections (clients and authorities).- Manufacturing records correction.- GMP documentation management.- Revision of reports and audit trails of inspection machines.- Conducting internal audits.- Detection and management of defects in packaging material.- Providing GMP training to internal personel.- Working on a FDA environment- Familiarise with Trackwise, SAP, IP6.

Madrid Y Alrededores, España

- Supporting with submissions and notifications to Ethics Committee and Regulatory Authorities (Spain and Italy).- Helping on the clinical trials Set-up, which includes ensuring each site has the trial materials and investigational medicinal product.- Perform site selection, initiation, monitoring, and close out visits in accordance with contracted scope of work and good clinical practice, under close supervision.- Create and maintain appropriate documentation regarding site management, monitoring visit findings and actions plans by submitting regular visit reports, generating follow-up letters and other required study documentation, under close supervision.- Archiving study documentation and correspondence.- Supporting to design data collection forms, as case reports forms (CRFs).- Supporting the manage progress by tracking case report form (CRF) completion and data query resolution.- Supporting CRAs with the visit reports and filing and collecting trial documentation.- Ensuring all unused trial supplies are accounted for.- Assisting with the close-out trial sites on completion of the trial. - Breast Cancer.- Inflammatory Bowel Disease.- Neuropathic Pain.

San Sebastián De Los Reyes, Madrid

- Writing Media Fill final reports, Validation Plans, OQ (Operational Qualification)/PQ (Process Qualification) protocols and performing.their execution and final report.- Analysis of the Process Capacity.- Redaction of SOPs (Standard Operating Procedures).- Resolution of No Conformities.- Redaction of a wide variety of internal reports.- Risk Assessment.- Programming Vision Systems and performance their validation.- Dealing with Incidences and Deviations.- Management of CAPAs (Corrective and Preventive Actions).

In charge of the complete management of the pharmacy.

Calle De Julian Camarillo, 35, Madrid

- Documenting preparation guides for clean room utilities. - Delivering reclamations to suppliers.- Dealing with deviations and incidences.- Management of CAPAs (Corrective and Preventive Actions). - Analysis of time by using SAP.

Grado En Farmacia

Máster En Monitorización De Ensayos Clínicos, Clinical Trial Monitoring

Grado, Psychology