Jpc - 1251 - Life science consultant, computerized system validation we are looking for enthusiasts kvalito consulting group is a strategic partner and global life science network for regulated industries with a focus on quality. Headquartered in basel, switzerland, we have subsidiaries in germany, czech republic, ireland and malaysia. With our enthusiasm for progressive technologies and our in-Depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-Leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, kvalito works with reliable technology partners worldwide. For more information, please visit us at (Informação Confidencial) life science consultant, computerized system validation contract: permanent or freelance the life science consultant, computerized system validation is responsible for planning, implementing, and maintaining computerized system validation for our clients sap s/4 hana implementation, ensuring it meets intended uses and complies with applicable regulations, current industry practices, and company procedures. The engineer will work closely with it enterprise applications teams, business process owners, and key users to gather and document user requirements from stakeholders in both languages and manage validation activities of cross-Functional teams. Major accountabilities manage the entire gxp change control process from initiation to closure for the sap s/4 hana implementation, ensuring it meets the requirements of project stakeholders. This includes global gxp systems used across various regions. Manage the entire gxp change control process from initiation to closure for the sap s/4 hana implementation, ensuring it meets requirements from project stakeholders and complies with anvisa regulations. Work closely with it enterprise applications teams, business process owners, and key users to gather and document user requirements from business stakeholders in portuguese and english to establish the intended use of the sap s/4 hana system. Collaborate with project stakeholders to author validation deliverables (e.G. Quality risk assessment, validation plan & report, test plan report, iq/oq/pq, inventory list, data migration plan and report, operational handbook etc.) in both languages and revise accordingly based on guidance and feedback from the quality team. Manage validation activities of cross-Functional teams to ensure the validation effort is executed to plan and properly documented in the appropriate validation documents. Support resolution and documentation of protocol and test discrepancies in both portuguese and english. Ensure the sap s/4 hana system remains in compliance with anvisa regulations and internal procedures as changes to the system are made. Help maintain post go-Live activities such as managing user onboarding documentation, revision release notes assessment for validation impact, assisting with quarterly system access review documentation, etc., in both languages. Maintain computerized system validation documentation for the sap s/4 hana implementation in portuguese and english. Qualifications education degree in science, engineering or equivalent language english fluently (written & spoken) experience at least 5 y ears of experience in computerized system validation, preferably in the pharmaceutical or biotechnology industry. Proven experience in sap validation. Strong understanding of gxp regulations, anvisa regulations, and industry practices excellent communication and collaboration skills, with the ability to work effectively with cross-Functional teams and stakeholders in both languages. Strong analytical, problem-Solving, and project management skills familiarity with validation tools and software testing methodologies ability to work independently and manage multiple priorities in a fast-Paced environment. Willingness to travel to and work at the são paulo project location. We offer great benefits flat hierarchies and responsibility from the beginning people-Oriented culture diversity and inclusion-Focused environment global client projects in a multinational environment flexible working hours and home office individual professional development, training, and coaching unlimited full employment contract excellent remuneration package consisting of a competitive salary plus a substantial bonus contact if you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)including your: cv, cover letter and supporting documents (i.E., diplomas, certificates, references) availability - Earliest start date salary expectations location preference we are looking forward to your application. Your kvalito team.
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