nicla ciccotti

plant engineer

About

// Quality Assurance // Compliance // Regulatory // Validation Consultant // This reality allowed me to approach qualifications world from the point of view of quality assurance, quality compliance and regulation activities, as a support to the engineering and validation departments in the execution of improvement projects and qualifications itself. My experiences have offered me opportunities to adapt to new environments. I have learned how important it is to be flexible and make use of my own resources, and how to communicate with colleagues and clients in order to meet work demands. Also schedule and priorities tasks in order to deliver quality results and meet deadlines.

Country

italy

City

naples

Industry

pharmaceuticals

Skill

pharmaceutical industry, buone pratiche, gmp, quality assurance, process validation, capa, archive management, aseptic process production, process technologies, business plan, public speaking, strategia di marketing, management, farmacisti, strategia d'impresa, convalida, annual product review, report kpi, analisi dei trend, change management, sop, qualifica di installazione, qaulifica operativa, ioq, fda, regulatory affairs, project management, microsoft word, microsoft excel, microsoft office, documentazione, iso, leadership, farmaceutica, lingua inglese, continuous improvement, change control, powerpoint, minitab, microsoft project, autocad

Experience

automation and validation engineer per capuabioservices and royal frieslandcampina

incotec s.a.s

2018-6 - 2018-12 · 7 mos

* Work in all aspects of automation and validation of industrial equipment and qualification projects. * Support installation of pharmaceutical equipment (construction management); * Organization / planning of resources and activities (SAT execution); * Writing and executing of Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). * Writing and review of Standard operating procedure (SOP), Technical Assessment, GAP analysis. Complies with cGMP, safety requirements, and company policies.

qualification consultant per philip morris international in collaboration with cai

incotec s.a.s

2018-5 - 2018-6 · 2 mos

* Primary Production: * execution of IOQ qualification protocols * management and scheduling of surrounding activities

qualification consultant per philip morris international in collaboration with sgs

incotec s.a.s

2016-11 - 2017-12 · 1 yr 2 mos

* Secondary Production: * execution of IOQ qualification protocols * management and scheduling of surrounding activities

automation and validation engineer - validation consultant

incotec s.a.s

2016-7 - 2016-11 · 5 mos

As independent worker in managing all aspects of projects

pharmacist

farmacia caretti dr pietro caretti

2011-3 - 2011-8 · 6 mos

Trainee :sales support and accounting

quality assurance expert - engineering and validation

gsk

2015-3 - 2016-7 · 1 yr 5 mos

* Perform checks and audits for qualification and validation activities in order to promote preventive actions and the adoption of corrective actions to remedy the causes of deviations or product recall (CAPA – Corrective Action Preventive Action). * Responsible for review and approval of validation protocols and reports of manufacturing processes and systems. * Change requests (CR) and deviations (DR): impact evaluation on qualification and validation. * Technical writing of Standard Operating Procedures (SOP),Technical Reports (TR) and Risk Assessment; * Key Performance Indicators (KPI): providing detailed reports in order to promote remediation projects; * Experience with FDA and AIFA inspections.

pharmacist

farmacia santo spirito dr antonio iuliano

2013-5 - 2014-2 · 10 mos

Internship/Postgraduate: sales support and warehouse

plant engineer

capua bioservices

2019-1 - Present · 7 yrs 9 mos

Day to day tasks include determining standards and policies for installation, modification, quality control, testing, inspection and maintenance, inspecting plant and machinery to ensure optimum performance, directing the maintenance of plant buildings and equipment, scheduling and planning project projects for the continuous improvement of production departments.

Education

kaplan international college - manchester (uk)

english

2014-1 - 2014-1 · 1 mo

Advanced level certificate in English, passed IELTS Academic: B2 level according to the CEFR

kaplan international college - manchester (uk)

english

2013-1 - 2014-1 · 1 yr 1 mo

Advanced level certificate in English, passed IELTS Academic: B2 level according to the CEFR

master in data intelligence e strategie decisionali - la sapienza

pharmacy

2015-1 - 2016-1 · 1 yr 1 mo

Training program to acquire thorough knowledge of current methods used in the production and control of medicinal products and their distribution, Good Manufacturing Practices (GMP), industrial management systems, evaluation of product cost as well as rules governing drug registration, manufacture and documentation. Thesis: "Quality Systems Development within Aseptic Production: normative and operational aspects, continuous process verification”. Analysis of ISO and GMP for aseptic production management: classification of areas, environmental monitoring, validation of systems and processes, continuous improvement.

università degli studi di napoli federico ii

pharmacy

2008-1 - 2013-1 · 5 yrs 1 mo

Thesis: “Pain therapy: chemical and therapeutic aspects”. - November 2013: State examination for qualification as a pharmacist. - January 2014: Member of the Order of Pharmacists of the Province of Naples (Ordine dei Farmacisti della provincial di Napoli).