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1 VAGA DE Designer EM São Paulo / SP
Designer
Nome da empresa disponível para cadastrados.
A combinar
São Paulo / SP
Home Office
Efetivo/CLT
This is where you save and sustain lives at baxter, we are deeply connected by our mission. No matter your role at baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform we create a place where we are happy, successful and inspire each other. This is where you can do your best us at the intersection of saving and sustaining liveswhere your purpose accelerates our director/qmr is responsible for quality assurance and quality control for the sao paulo site. This person will guarantee the quality of services and products according to local regulations and global requirements and achieve the best results through quality strategy and responsibilities:- Establishes strategy for ensuring quality management systems are implemented and maintained in accordance with applicable baxter global quality guidelines, procedures, and strategy as well as external regulatory agency requirements.- Set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement.- Drive glp with excellence.- Responsible for qa review, approval, and quality operational oversight of internal manufacturing documentation, defining and agreeing on the follow up of corrective and preventative actions from changes and deviations during manufacture.- Be responsible for the delivery of qa activities for their assigned portfolio of projects. Accountable for aligning all qa activities across a project and empowered to resolve any project quality issues across the qa sections.- Complement brazilian slt bringing quality and safety advice to the affiliates strategy.- Partner with business to plan and execute product launches, bringing visibility of quality requirements, costs, timelines and investments needed.- Support a strong lean culture that promotes standardization, simplification and continuous improvement.- Preparation of executive summaries as required- Responsible for planning and execute any remediation or implementation of new gqp or regulations.- Accountable for budget and capex within quality organization and related kpis- A broad and comprehensive understanding of quality systems and gmp.- An all-Inclusive understanding of the pharmaceutical/drug development process.- Solid understanding and experience in the development and manufacture of combination device products.- Understanding of project management, supply chain and laboratory processesqualifications:- Bachelors degree in biochemistry pharmacy preferred or equivalent science degree/masters preferred.- Long term interaction with anvisa and its regulations.- Minimum of 15 years of working within a pharmaceutical gmp environment, preferably within a sterile or aseptic environment.- Fda experience is preferable.- Fluency in english required.- Proven leadership and excellent communication and influence skills.- Long range and visibility and planning capability.- Strong leadership skill, with focus on people development and culture as1reasonable accommodationsrecruitment fraud noticebaxter has discovered incidents of employment scams, where fraudulent parties pose as baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our recruitment fraud notice..
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