Rafael Marques de Almeida

Date of birth **-July-*987, Valid US VISA B1/B2

Address: Street Dr. João Tavares, Ed. S Vicente, N 158, Apt 22, Neighborhood Vila Espírito Santo, Sorocaba - SP - Brazil - Zip Code: 18051-320

Mobile: +55-24-999**-**** - E-mail: adbjam@r.postjobfree.com LinkedIn: br.linkedin.com/in/rafaelmalmeida - Skype: rafaelmalmeida PROFILE

Professional with more than five years of experience managing, developing and implementing complex projects in Computerized Systems Validation and Equipment Qualification areas. Core competencies include: Risk management and assessment, teamwork, results orientation, problem solving, communication, customer orientation and leadership. Proficient in:

- Computerized Systems Validation including validation of Cloud Computing Systems;

- Validation of Electronic Spreadsheets;

- Cloud Service Providers Qualification;

- Equipment Qualification;

- Development of the whole Validation and Qualification life cycle documents;

- 21 CFR part 11;

- FDA, EMA and ANVISA rules and regulations;

- SOX;

- SDLC (System Development Life Cycle);

- SAP;

- GAMP 5.

- Computerized Systems Validation Guide - Anvisa;

- ITIL;

- Project Management (PMBOK);

- Microsoft Office (Word, PowerPoint, Excel, MS Project, Visio and Outlook) and Adobe programs. PROFESSIONAL EXPERICENCE

Five Consultoria – Sorocaba/SP - Brazil

Five is a company specialized in Computerized System Validation, Equipment and Utilities Qualification with operational focus on life sciences industries, which brings together pharmaceutical, pharmachemical, medical products, toiletries, perfumes, cosmetics, veterinary and medical gases companies as well as their suppliers. Role:

CSV Supervisor – Present.

CSV Project Leader – Mar/2018 to Aug/2018.

CSV Analyst – Mar/2016 to Mar/2018.

Activities:

- Participated in the management and coordination of the development of a global cloud system (GO!FIVE) focused on automatization of the entire computerized systems validation lifecycle.

- Supervisor of multiple validation projects providing technical support for the analysts involved and reviewer of all documentation related to the projects.

- Development, implementation and execution of all activities and documents related to the computerized systems validation.

- As supervisor, I provide internal and external training, I manage all the project validation, also I establish the validation strategies, carry out stakeholder management, in addition to that I provide all the necessary technical support to the analysts in the projects.

- Qualification of cloud service providers.

- I was responsible for represent the IT Quality Compliance group at Boehringer Ingelheim Brazil Site, ensuring that the methodology, regulations and internal procedures (change control, GxP impact assessment, documentation assessment, and so on.) are followed. During my work in this position, I had the opportunity to participate in an internal event, with the global team lasting 1 week in Danbury/CT, USA, in order to align the internal procedures and methods to be replicated on other Boehringer Ingelheim sites.

- Summary of validation projects in which I had the opportunity to act: HVAC system from Daiichi Sankyo Brazil;

BPCS (ERP) and ISMetrology systems from 3M;

Traceability system from Johnson & Johnson;

SAP modules modifications (Project One e Back to Basics) from Johnson & Johnson; Laboratory systems as Empower, OpenLab, WinLab, UV Varian, TotalChrom from Fagron; Evolutio (WMS) system from Geolab;

Protheus (ERP) system from Catalent;

Empower system from Zodiac;

IdSecure Biometry system from Celgene;

iFIX (Scada) system from Chiesi;

Openlab system from Brainfarma;

Qualiex system from Forlogic;

GO!FIVE system from Five Consultoria;

SAP S/4 Hana system from RIOgaleão.

Prati Donaduzzi & Cia Ltda – Toledo/PR - Brazil

Company focused on the production of generic drugs, being the largest supplier to public agencies in Brazil. Role:

CSV Analyst – May/2015 to Mar/2016.

Activities:

- Validation of computerized systems and electronic spreadsheets.

- Change management and evaluation of systems incidents.

- Schedule and inventory management.

- Adequation of legacy computerized systems, to comply with Anvisa and FDA rules and regulations.

- Elaboration, implementation and execution of the entire documentation related to the validation of computerized systems.

Novartis Biosciences – Resende/RJ - Brazil

Novartis Biosciences is a global health care company that offers solutions to meet the evolving needs of patients worldwide.

Role:

CSV and Qualification Analyst – Mar/2014 to Apr/2015. Validation and Qualification Trainee – Sep/2013 to Mar/2014. Activities:

- Validation of computerized systems and electronic spreadsheets.

- Change management and evaluation of systems incidents.

- Qualification of quality control laboratory equipment.

- Monitoring of calibration and qualification activities with suppliers.

- Qualification and monitoring of temperature and humidity in warehouse and during transport.

- Participation in the change management group related to computerized systems.

- Schedule and inventory management.

- Review and elaboration of standard operational procedures and training.

- Development, revision and archival of all computerized systems validation and equipment qualification documents.

EDUCATION

• Specialization:

Project Management – FGV – SP – Expected Conclusion in JUL/2020.

• University:

Bachelor’s degree on Information Technology – Estácio de Sá University – Sorocaba/SP – Graduated in 2019.

• University:

Bachelor’s degree on Product Design – Unifoa University – Volta Redonda/RJ – Graduated in 2011.

• University:

Bachelor’s degree on Graphic Design – Unifoa University – Volta Redonda/RJ – Graduated in 2010. COURSES & EVENTS

• Active member of the TI/TA/CSV Sindusfarma group - São Paulo/SP – 2018, 2019, 2020.

• Member of the team responsible to write the Cloud Service Providers Qualification Guide nº31 from Sindusfarma São Paulo/SP – 2019.

• Participated in the event with the Global IT QC team in Boehringer Ingelheim USA on behalf of BI Brazil site – Danbury/CT– USA – 2018.

• Speaker at FIVECON 2018 about Cloud Computing: Key Points to Qualification – São Paulo/SP – 2018.

• Lean Validation: Leveraging the NIST Cybersecurity Framework for Computer Systems Validation – Compliance 4All – Webinar – 2017.

• Medical Device Cybersecurity: The Landscape of Quicksand – Compliance 4All – Webinar – 2017.

• Participated on Cybersecurity event from Wayra Brazil – São Paulo/SP – 2017.

• Speaker at FIVECON 2017 about Cloud Computing: main challenges for Computerized Systems Validation – São Paulo/SP – 2017.

• Cloud Computing – ECA Academy - Berlin/Germany - 2017.

• Computerized Systems Validation with GAMP5 approach – ISPE Brazil Affiliate – São Paulo/SP – 2014.

• Electronic Spreadsheet Validation – ISPE Brazil Affiliate – São Paulo/SP – 2014. LANGUAGES

• English – Fluent.

• Portuguese – Native language.

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