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HRBP/Site HR · 賽諾菲

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職位介紹: About us At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients. Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases. ~ 43.07Bn€ Net Sales FY23 ~90 countries ~ 91K employees ~ 59 manufacturing sites ~ 20 R&D sites Our team and your role The Regional Hub Manufacturing & Supply (M&S) Services is responsible for delivering and supporting M&S teams in partnership with Business and Digital, and drive priority and transformative initiatives across M&S. The team members of Regional Hub M&S Quality Services (Product Complaints) will act as partners in carrying out tasks and fulfilling responsibilities to support identified and established global quality processes to the Global hub. The Regional Hub Product Technical Complaints team handles intake activities of complaint processing. Key Accountabilities Common responsibilities: ● Handle Product Technical Complaints (PTC) for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. ● Collaborate with internal/external stakeholders via Cross functional teams, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments for complaint management. ● Ensure to complete all training in a timely manner. ● Process intake for complaints and evaluate, ensuring timely processing and closure of the complaints. ● Participate in ad-hoc meetings for product-specific complaint issues and provide feedback on complaint investigations. ● Manages and ensures the compliance of all Quality processes and documentation with applicable regulations/ Sanofi standards. Handle QMS records & any discrepancies and ensure completion within defined timelines. ● Ensure the documentation of Hub related GxP activities. ● Any other responsibilities as assigned/aligned by manager. ● Distribution of inquiry/complaints received within team for further processing. ● Facilitate periodic governance meetings with respective stakeholders and creation of presentations, SOPs, and training materials. ● Periodic report downloads from relevant tools to ensure all the complaints are received, processed & closed in timely manner. ● Perform quality checks on PTC activities and support audits/ regulatory inspections. ● Strive for continuous improvement by following standardization, simplification, digitalization to achieve efficiency. Other responsibilities ● Act as a regional hub for the assigned countries. Follow up with the complainant for additional information and complaint sample management. ● Determine if the PTC is associated with an Adverse Event, Pharmacovigilance (PV) Special Situation. Ensure respective teams are communicated (As applicable). ● Ensure to complete all the required information and forward the complaint to Global Hub. ● Ensure acknowledgement of Complaint and/or response to Complainant (as applicable). ● Health authority called-in complaints, prioritized complaints and suspected counterfeit complaints are handled with the utmost urgency and in strict compliance with both global and country-specific regulatory requirement. ● Maintain compliance with all relevant regulatory requirements for complaint management and reporting. ● Communicate with the complainant (as applicable) for any other request/ additional information related to complaint and complaint sample. About you Experience ● Minimum 8 – 10 years of related experience in the pharmaceutical industry. ● Knowledge of cGMP’s, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. ● Should be knowledgeable in Quality functions of pharmaceutical industry. ● Experience of working on manufacturing sites is an added advantage. Education ● Bachelor’s or Masters in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Soft skills ● Proficient in problem-solving, attention to detail, and organizational skills. ● Work in a team-oriented, flexible, and proactive manner. ● Analytical skills and ability to multitask in a stressful environment. Technical skills ● Technical knowledge on the Product complaints ● Understanding and knowledge on Quality Management System related activities Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our and check out our Diversity Equity and Inclusion actions at !

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公司簡介

賽諾菲是一家全球領先的創(chuàng)新醫(yī)藥健康企業(yè)，以“追尋科學奇跡，煥發(fā)生命光彩”為使命。作為改革開放后首批進入中國的跨國企業(yè)之一，賽諾菲于1982年便在中國建立了辦公室，目前擁有12處多元模式的辦公室，3家生產(chǎn)基地，4大研發(fā)基地和1個數(shù)字創(chuàng)新中心，多元化業(yè)務覆蓋制藥、人用疫苗和消費者保健。賽諾菲與中國同心同行，致力于將創(chuàng)新藥品和疫苗加速引進中國，不斷變革醫(yī)療實踐，造福更多中國百姓，也為合作伙伴、社區(qū)和員工創(chuàng)造更美好的生活。如需了解更多信息，請訪問jobs.sanofi.cn，或關注“賽諾菲中國”微信公眾號。

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