1 VAGA DE Analista Desenvolvedor EM Macau / RN

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Analista Desenvolvedor

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A combinar

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Home Office

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Descrição da vaga de Analista Desenvolvedor:

Jpc - 1072 - Life science consultant: computerized system validation and it quality 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 and it quality location: remote the purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency. Responsibilities: the compliance scope includes gxp-Regulated computerized systems, site it security contact, it risk management, data privacy, and it operational process for non-Gxp system life cycle part of the virtual team in supporting global it quality. Liaise with global it quality and local quality to be the owner of local it quality policies (qap), quality-Related operation process (sop), tools, and standards to the stakeholders (e.G., business, global functions, global site it) develop/maintain quality procedures along the life cycle of in-Scope computerized systems keep compliance information in itsm tool updated, site it risk register, and associated mitigation activities support project activities as it quality assurance, for local gxp it projects support it lifecycle processes such as change control and document management provide training related to it systems quality and compliance support site business, when needed, as an extension of site quality and global it quality, for the topic of data retention, data privacy & electronic change management process plan and implement qualification and computerized system validation (csv) activities as well as projects of new and existing regulated computerized systems according to internal and external requirements for all departments advice and support system owners to build and maintain gmp and gxp systems support application and infrastructure classifications (gxp versus non-Gxp) develop and approve specific computer system validation documentation such as quality, validation, and test plans and report minimum qualification and experience education bachelor or master degree in life sciences, chemistry, computer science, engineering or similar. Language must have: fluent in mandarin business english required 8+ years of experience in computerized system validation within life science industry hard skills experienced in computerized system validation, such as but not limited to sap, mes, lims, trackwise, veeva, etc. Must have knowledge of chinese csv regulations and standards like cfda/nmpa knowledge of regulations and standards such as gamp5, iso, ich, eudralex, fda, ema, who, pic/s, and sox practical experience in and passion for the information governance, it quality and compliance, and service management. Soft skills excellent people management, leadership, and decision-Making skills. Ability to facilitate a holistic perspective and understand business needs. Motivated to continuously expand her/his knowledge of the life science industry. Strong communication and problem-Solving skills. Ability to work globally to coordinate the work of associates at all levels. Considerable organization awareness (e.G., the interrelationship of departments, business priorities) including experience in working cross-Functionally and in global teams across cultures. 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.