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Specialist Clinical QA process, Sant Cugat del Valles



Grifols Shared Services North America, Inc


Sant Cugat del Valles, Spain 

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Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries. We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise. **WHO WE ARE** Grifols is a global healthcare company with more than 75 years of history improving the health and well-being of people around the world. We produce essential plasma medicines for patients and provide hospitals, pharmacies, and healthcare professionals with tools, information, and services they need to efficiently deliver expert medical care. We are present in more than 100 countries, with global headquarters in Barcelona, Spain, where the company was founded. As a company committed to serving people, we seek to hire and retain the very best employees. Our day-today corporate culture reflects the Grifols Spirit, which is defined by our Values. From **Clinical Quality Assurance department** we are looking for a **IGI + D Specialist QA Process** . **YOUR TASK AND RESPONSABILITIES** Provides sponsor quality oversight of clinical activities ensuring that investigator, vendors, facility and system audits are conducted, communicating any critical compliance risks noted from these activities to senior management and ensuring that corrective actions are implemented. Ensuring that clinical trial activities sponsored by Grifols are conducted in compliance with ICH-GCP regulations, regulatory requirements and Grifols requirements. **Primary Responsibilities for role:** + Review master and SOP documents and oversees the implementation and maintenance of these procedures. + Ensure the SOPs are compliance with relevant regulations (e.g., GLP, GCP), regulatory requirements and industry standards. + Provide quality oversight and coordinate activities associated with TMF/eTMF management. + Ensure that TMF/eTMF meet compliance standards to study protocol, GCPs, study manuals, SOPs (Grifols/contracted CROs) and applicable regulatory and country requirements and thereby ensure that patients rights are respected, that their safety is assured, and that the trial data are reliable. + Interact with Clinical department to provide guidance and consultancy to resolve compliance issues. + Give input to clinical quality strategic decisions. + Assist the manager in reviewing and overseeing the Quality System Plan for clinical programs. + Ensure vendor compliance with the protocol, Clinical Operations plan, GCPs and contractual obligations aligned with Global Clinical objectives. + Develop and manage quality process documents under manager supervision. + Promote improvements in the quality procedures to improve the quality and efficiency. **WHO YOU ARE** + Life Sciences Master and Degree. + A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials. + Native level of Spanish and Advanced in English. + Ability and willingness to travel. + Ability to work both in a team and independently. + Ability to meet deadlines, multitasks, and prioritize based on study needs. + Ability to works on assignments with a diverse scope. + Ability to work with a very limited direct supervision. + Advanced knowledge of ICH/GCP Guideline. + Advanced knowledge of electronic data capture (EDC) systems. + Advanced knowledge of medical terminology. + Advanced knowledge of the therapeutic areas assigned. + Routinely demonstrates mastery of technical skills **WHAT WE OFFER** It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com at http://www.grifols.com/ It you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply! We look forward to receiving your application! Grifols is an equal opportunity employer. **Contract of Employment:** Permanent position **Location: Sant Cugat del Vallès, Barcelona, Spain** Learn more about Grifols at http://www.grifols.com/es/web/international/home
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