
System Validation Specialist
Há 5 dias
We are seeking an experienced System Validation Expert to join our team. This role requires a strong understanding of regulatory requirements and industry standards for Medical Devices.
- 7-10 years' experience in Computer System Validation of Regulatory Information Management systems used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP).
- Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide project teams.
- Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.
The ideal candidate will have a solid understanding of SDLC, Jira, xRay, code repository like bitbucket and change control/ management systems like ServiceNow.
Requirements:- At least 3 years of experience in system validation.
- Proven track record of successfully validating complex systems.
- Excellent communication and interpersonal skills.
Benefits:
This is a great opportunity to work with a dynamic team and contribute to the development of innovative solutions.
Others:
The selected candidate will be required to work closely with the project team to ensure that all tasks are completed on time and within budget.
-
Validation Specialist
Há 16 horas
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$93.100 - R$121.110Our organization is seeking an experienced Validation Specialist to lead the validation of computer systems in medical devices applications. The successful candidate will be responsible for ensuring compliance with FDA guidelines and industry standards such as GAMP. About the Role:The Validation Lead will work closely with cross-functional teams to plan,...
-
System Validation Expert
Há 3 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$120.000 - R$140.000System Validation Expert">We are seeking a highly experienced system validation expert to lead computer system validation projects. The ideal candidate will have in-depth knowledge of regulatory requirements, specifically FDA guidelines and industry standards (GAMP), as well as 21 CFR Part 11 and Risk Based Approach.">The successful candidate will have the...
-
Computer System Validation Specialist
1 semana atrás
São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$180.000 - R$240.000As a highly skilled professional in Computer System Validation, you will be responsible for ensuring the integrity and compliance of regulatory information management systems used in medical devices. This role requires a strong understanding of FDA guidance's and industry standards (i.e., GAMP), as well as experience in drafting and approving CSV...
-
Validation Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil GWM Brasil Tempo inteiro**Validation Engineer Specialist****Job Mission**Ensure robust validation for new projects to Brazilian market, attending program needs and key project milestones.As a team, contribute to define and clarify the validation processes aligned with headquarters, generate engineering solutions, reports and develop team members.**Main Responsibilities**Define and...
-
Validation Expert
Há 4 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$80.000 - R$150.000Job Title: Validation LeadA high-level validation professional is sought after to lead computer system validation projects. The ideal candidate will possess extensive experience in validating regulatory information management systems used in medical devices.7-10 years' experience in Computer System ValidationStrong understanding of 21 CFR Part 11 and Risk...
-
Tech Validation Specialist
Há 4 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$135.000 - R$165.000Job SummaryLead the validation of computer systems in a medical device regulatory information management system environment. Apply FDA guidance and industry standards, such as GAMP, to ensure compliance.7-10 years of experience in computer system validationStrong understanding of 21 CFR Part 11 and risk-based approachExperience in drafting and approving CSV...
-
Engineering Validation Specialist
Há 3 dias
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro €50.000 - €80.000Engineering Validation Specialist OpportunityWe are seeking a skilled Validation Engineer to support various aspects of our validation process.Sterilization: Autoclaves, SIP of vesselsCleaning: Parts Washer and CIP of vesselsIsolator operations: Filling, Sterility & Material handlingThe ideal candidate will have experience in sterilization, cleaning, and...
-
Senior Scientific Validation Specialist
1 semana atrás
São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro €75.000 - €95.000Job Description:Pharma Validation Engineer RoleWe are seeking an experienced and skilled Pharma Validation Engineer to support various aspects of validation, including sterilization, cleaning, isolator qualification, and controlled temperature unit validation.The successful candidate will design, author, review, approve, and execute qualification/validation...
-
Specialist - B2B Systems
1 semana atrás
São Paulo, São Paulo, Brasil On Tempo inteiroJoin to apply for the Specialist - B2B Systems role at On Join to apply for the Specialist - B2B Systems role at On In shortAs a Specialist - B2B Systems, you will work on the ERP system that enables our growth and helps to bridge the gap between our
-
Validation Lead
3 semanas atrás
São Paulo, São Paulo, Brasil Decision group Tempo inteiroNível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...