Jose Nieto Roldán

Coordinate and manage the Quality Assurance team. Main activities: GMP documentation. Complaints. Deviations, non-conforming materials, OOS. Recalls. CAPA. Batch documentation review. Annual Product Review. Suppliers. Audits / Inspections. Validation Plan and Protocols-Reports. Stability Plan-Studies-Protocols-Reports. Calibration. Regulatory Compliance. Change control. SOPs. SMF-Quality Manual-Quality Agreements. Review Quality System Report. Training. Budgets. Stock monitoring. KPIs.

Certification of the finished product batch for release to the market. Ensuring compliance with GMP. Marketing Authorization (MA) and any additional requirements o legislative. Recalls, report falsified situations about products. Review and approval of protocols and reports (validation/qualification/PQR...). Review and approval the Site Master File (annually) / Quality Manual. Responsible for the edition of Standard Operating Procedures of the area itself. Key contact person with Authorities.

Review of internal manufacturing and analysis procedures, raw material and finished product specifications, whether for our own products or those of clients or subcontracted third parties, against what is declared in the corresponding registered dossiers. Management of Change Controls system. SMF / Quality Manual. SOPs. Quality Agreements.

Department: Quality - Update and compliance of the documentation. - Variations of the Module 3, Quality, of the CTD. - Management of the GMPs, different certificates. - Management of Teleconferences with the different affiliates of the countries. - Management of Transfer activities of incoming products, and all the activities involved.

Departamento: Producción - Calidad