Carlos Sanz Del Olmo

Injectables (several types of Heparins) and vaccines (mRNA-1273 Covid19, Influenza) RESPONSIBILITIES  Leadership and management of the Production Documentation Group Department in a pharmaceutical company. Seven people in charge.  Activities managed: SOPs, Complaints, Deviations, Investigations, CAPAs, PQRs, Change Controls, GMP Training, Manufacturing Dossiers Review, etc. ACHIEVEMENTS  Collaboration in projected approval of new manufacturing lines by AEMPS and arising problem solving.

Soft gelatin capsules (more than 1000 types of analgesics, food supplements) RESPONSIBILITIES  Analyze project requirements to find bugs and eliminate issues in Pharma production.  Activities managed: Deviations, Complaints, CAPAs, Manufacturing Dossiers Review, Internal audits, etc. ACHIEVEMENTS  IT projects validation & implementation (ERP, DMS).

OTC Drug Products and Food Supplements (USA market) RESPONSIBILITIES  Implementation and enforcement of GMP Quality System and Food Safety procedures.  Activities managed: Approval of Lots, Testing, Stability, Complaints, Deviation, Validation, Internal & External audits (FDA GMP 21CFR111, GMP 21CFR211, IFS, BRC, Halal, Kosher, customers), QAA, Labelling Review, Technical Sheets. ACHIEVEMENTS  Registration of products under USA FDA authorities and customers. Obtention of GMP certifications.

API Manufacturing (contrast media)  Leadership and management of QEHS. Up to 4 people in charge.  Batch Approval, Internal and External QEHS Audits, Calibration, Qualification, Validation, Deviations, Complaints, CAPAs, SOPs, QAA, GMP Training, MBR, APR, PQR, KPI, Supplier assessments, Records keeping, etc.  Customer Requests solving, Declarations, Questionnaires, etc.  Obtention of several product registration and certifications (FDA, AEMPS, ISO 9001, CEP EDQM, eCTD DMF, etc.)

API Manufacturing (contrast media) RESPONSIBILITIES  Collaboration in management of Integrated Management System (QEHS).  Activities managed in Quality: Internal QEHS Audits, Calibration, Qualification, Validation, Deviations, Complaints, CAPAs, SOPs, GMP Training, MBR, APR, PQR, KPI, Supplier assessments, Records keeping, etc. ACHIEVEMENTS  Collaboration in obtention of several product registration and certifications (FDA, AEMPS, ISO 9001, CEP EDQM, eCTD DMF USA, CANADA, AUSTRALIA, JAPAN, etc.).

Qualified Person according to Directive 2001/83/EC

Thesis: Environmental Management Systems in Mining (ISO 14001 and EMAS). Application to the MINING-HYDROMETALLURGICAL PROJECT LAS CRUCES (Seville - SPAIN)

Certified the Sufficiency for the development of research tasks

FIVE YEARS CYCLE