Validation Consultant

Technical expertise to define approaches and execution of system validation activities in accordance with cGxP, CFR Parts 11, 210 & 211, Annex 11, GAMP5 and other applicable standards, regulations, procedures and industry trends such as risk-based CSA.

Coordinate and collaborate with third-parties for the creation, execution and closure of validation deliverables for various cGxP IT solutions and projects.

Develop and manage project documentation for SDLC requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.

Assist in performing impact assessments and work with technical SMEs to close out IT related CAPAs

Work with project teams to select methods and techniques for obtaining desirable solutions for each project and work with QA to ensure compliance with regulations.

Participate in change control meetings and act as primary point of contact for core solution teams regarding change management, quality assurance and compliance management.

Habilidades: Testes / Garantia de qualidade, Wireless Certification (CSA, FCC, IEC, FAA, IEEE, CE, Atex), Wireless Radio Frequency Engineering, Testes de Usabilidade, Teste de Website

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Acerca do Empregador:
( 7 comentários ) ghaziabad, India

ID do Projeto: #28271404

4 freelancers estão ofertando em média ₹68715 nesse trabalho


---TESTING EXPERT--- I am a talented and experienced Senior Tester looking to be hired. In my work experience of more than 7 years, I have versatility as a functional and automation tester which involves test planni Mais

₹37500 INR em 1 dia
(11 Comentários)

Hello Greetings... I am a CSV expert from India. I have more than 8 years of experience End to End regulatory requirement for software, 21CFR part 11, Validation (Preparation of URS, Risk Assessment, DS, IQ, OQ, PQ, Mais

₹111111 INR in 10 dias
(0 Comentários)

back end testing and selenium exp. Back end testing which make sure all input data stored properly or not.

₹56250 INR in 7 dias
(0 Comentários)

Dear Sir, I am interested in this opportunity. PFB my experience summary.  10+ years of Industry experience in Technical Writing, Manual Testing , API Testing , App Testing and Test Automation;  Develop & obtain ap Mais

₹70000 INR in 7 dias
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