Validation Consultant

Descrição da Empresa

Luza Tecnologia, part of the Belgian De Cronos Groep, specializes in Microsoft technology. We prioritize employee well-being and development, and our partnership with Microsoft is rooted in collaboration, innovation, and delivering tailored solutions for complex business challenges. Our Microsoft Hub in Portugal supports Microsoft Partners across Europe, helping them maximize the potential of Microsoft technology. We value a positive work environment, based on the following pillars: Happy People, Diverse People, Microsoft Skills and Give Back Time.

Descrição da Função

This is a remote position from Portugal. We are looking for a skilled Validation Consultant to support the BIS eCompliance Team with activities related to Computer Systems Validation (CSV) and IT Quality Processes. Must-have: - Experience with management of Study Clinical Data - Experience in SAS Life Science Analytics Framework (e.g. implementation and / or operation of SAS tools, as well as the creation of the related documentation) Roles and responsibilities: - Write the software validation deliverables and initiate review and approval document lifecycles in EDMS. - Ensure the compliance with the methodology and SOP’s and ensure the use of relevant tools. - Ensure that the project validation deliverables are complete and consistent and delivered on time. - Ensure that project-related issues and deviations are recorded. - Assist in writing, reviewing Validation SOPs and templates. - Assist in resolving Computerized System Validation compliance issues. - Create and manage quality events such as change controls, deviations, CAPAs, etc. - Ensure timely, open, and effective communication to relevant stakeholders. - Ensure project timelines are followed, and potential issues are communicated. Requirements - Experience in biopharmaceutical or development sciences, validation consulting for computer systems, understanding of global regulatory requirements, attention to detail, and ability to work autonomously. - Preferable experience with clinical data management and SAS Life Science Analytics Framework. - Master's degree in Bio-engineering, Chemistry, Pharmacy, or related fields. - Proficiency in English and MS Office. - Experience with Veeva software systems or similar (ERP, QMS) is an asset. Benefits - Remote work - Food ticket - Health insurance - Training and access to certification vouchers - Work-life balance initiatives - Referral program - Birthday off - Give back day – enjoy a day to give back to society! Please send your updated CV to our email with the reference ZR_51_JOB

Localização

• Todo o país, Portugal