francesco spoto

system support and integration manager

About

Life Science professional with 10+ years of experience in Engineering, IT, Clinical, Quality & Validation projects for regulated industries. I have been working with growing responsibilities for several key players in Pharmaceuticals & Medical Devices across Europe. In the recent years, I focused more on the drug development domain with specific emphasis on global supply chain and early adoption of new technologies. Blockchain enthusiast and strong believer in the power of habits, I am always looking to work on something challenging that can make the difference!

Country

switzerland

City

basel

Industry

pharmaceuticals

Skill

validation, computer system validation, pharmaceutical industry, 21 cfr part 11, quality assurance, project management, gmp, medical devices, quality system, automation, gxp, engineering, clinical trials, gamp, software documentation, fda, pharmaceutical legislation, irt, pharmaceuticals, computerized system validation, autocad, user acceptance testing, change control, equipment validation, documentation, regulatory affairs, risk assessment, v&v, business analysis, business development, saas, life sciences, sop, supplier management, iec 62304, auditing, technical hiring, consulting, iso 13485, management, risk management, microsoft office, capa, 93/42/eec, business process improvement, clinical data management, good manufacturing practice, big data

Experience

advanced consultant

altran

2013-11 - 2014-12 · 1 yr 2 mos

consultant

altran

2012-11 - 2013-11 · 1 yr 1 mo

system support and integration manager

novartis

2020-1 - Present · 6 yrs 9 mos

advanced consultant - life sciences

altran switzerland

2015-1 - 2015-6 · 6 mos

it project manager - global remediation quality plan

depuy synthes companies

2014-6 - 2014-12 · 7 mos

* Multi-site team and project management aiming at re-validating high-critical computerized systems. * Approach: * As-Is analysis and To-Be scenario set up, according to company requirements: gaps identified and corrective actions defined * Definition of team and schedule for the manufacturing plant of Mezzovico * Establishment of strong relationship with Program Manager and focus on the buying-in and alignment with key stakeholders * Results: * 4 revalidation projects started in parallel in less than 30 days * 1 retirement project closed in less than 2 months * 100% of systems validated on time or ahead of schedule * Validation templates improved * Training to relevant personnel fully completed.

validation consultant

ctp tecnologie di processo

2010-3 - 2012-9 · 2 yrs 7 mos

Working as a Validation Consultant in the IT Compliance Dept of CTP, my main duties are assessing customers in taking risk-based decisions about validation of computerized systems and equipment, to be used for the production of pharmaceutical goods. Drawing up documents and establish validation approach are also important part of my job.

junior validation consultant

ctp tecnologie di processo

2009-7 - 2009-12 · 6 mos

Internship to develop MS thesis project. The job was focused on Computerized System Validation in Pharmaceutical companies, especially regarding SCADA system for environmental control in classified areas.