Luis Velasquez
Area Sales Manager at Uquifa
Based in Spain
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Seniority
Manager
Department
Sales & Business Development
Location
Spain
Industry
Pharmaceutical Manufacturing
Company size
376
Contact information
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l•••••••@uquifa.com
Phone
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Background
About Luis Velasquez
Pharmacist with experience of more of 20 years in differents areas (continuous compliance GxPs, laws, regulations and / or local guidelines and quality systems to third parties). Experience of 4 years in productions area (Liquids, Solids, Antibiotics and Injectable). Experience of 2 year in Pharmaceuticals forms for Development (I&D)- GxP experience with FDA, EMA, and Latam Regulations-Knowledge of ICH Q7, Q9 and Q10 - Management of SOP and QA documents (CAPAs, Deviations, Change Controls) related to the GMP, GDP and / or GxPs processes. Performance and follow of KPIs- Integrity Data according with MHRA GMP, Code of Federal Regulations, part 11 (CFR 21 part 11), EudraLex The Rules Governing Medicinal Products in the European Unión Volume 4- Continuous training on GDP and GMP -Support and audits with ISO 14644-1 standard. Guidance for Industry Sterile Drug Products, WHO good manufacturing practices for sterile pharmaceutical products (Annex 6)- Project Management, SAP and Trackwise- Experience with ISO 13485 - Control QMS in Clinical studies
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