Jose Luis Calderon Garcia, Employee at INSTITUTO NACIONAL DE TECNICA AEROESPACIAL and TRAMASA, S.L. (WATER TREATMENT)
Summary
Professional with good communication skills, leadership, organization and planning, capacity for teamwork, easy adaptation to work environments, serious and responsible character with ability to control difficult situations.
Wide experience in: Purified wáter Plants for Pharmaceutical Industry and Purification plant, Managing Teams and Departments, Project Management, Validation and Qualification in the pharmaceutical industry and similar companies, Systems Development and Implementation of Quality Management based on ISO 9000 and for Calibration and Testing Laboratories 17025, Metrology and Calibration activities, NDT, LOPD, Management Systems Information Security ISO / IEC 27001, Compliance and Quality Assurance.
Wide experience in: Purified wáter Plants for Pharmaceutical Industry and Purification plant, Managing Teams and Departments, Project Management, Validation and Qualification in the pharmaceutical industry and similar companies, Systems Development and Implementation of Quality Management based on ISO 9000 and for Calibration and Testing Laboratories 17025, Metrology and Calibration activities, NDT, LOPD, Management Systems Information Security ISO / IEC 27001, Compliance and Quality Assurance.
Contact info
Location: Madrid, Spain
Industry Experience
Education: Bachelor
Seniority: Expert, Engineer, Consultant
Years of experience: 20 years or above
Work Experience
Senior Consultant
Validation of equipment and automatic control systems (SCADAs, PLCs, DCSs, etc.).
CSV Responsible – FDA Strategic Compliance
Technical Area (Production):
- Equipment qualification.
- Development procedures.
CSV Responsible (QA/QC):
- Work group responsible to development and implementation of the CSV Policies and 21 CFR, part 11 of FDA.
- Equipment qualification.
- Development procedures.
CSV Responsible (QA/QC):
- Work group responsible to development and implementation of the CSV Policies and 21 CFR, part 11 of FDA.
QA Corporative – CSV SME
- Validation of: equipment, facilities, automatic control systems, computer systems, etc...
- Development of corporate policies to manage validation activities.
- Development of corporate policies to manage validation activities.
IT Compliance
Wyeth Pharma, Spain (now Phizer)
Development of Policies, Procedures, work instructions and documentation of qualifications to meet standards related to IT infrastructure.
Branch Manager
ASSI Sistemas e Instrumentación, S.L.
Technical and commercial management in calibration and Consulting activities
Support Engineer - Freelance
Attend support the needs of design engineering
EMI / EMC certification expert
INTA - National Institute for Aeronautical Technics (Madrid - Spain)
Assistance as an EMI / EMC expert in the certification of military aircraft
Industry Expertise
- Engineering
- Consultant
- Industrial Equipment
- Engineering Company
- Equipment Supplier
- Pharmaceutical Chemicals
- Technical Consulting
- Water & Sanitation
- Sanitation & Waste Management
- Health Care
- Industrial
- Pharmaceuticals
- Immunology
- Regulations & Policy
- Manufacturing