Manager/Senior Manager, APAC Quality Assurance
職位描述
RESPONSIBILITIES:The Quality Assurance GxP accountabilities are split between the QA teams as below:· * Audit team - GCP, GVP, GRP, LabGCP including strategy where applicable * LabsQA team - GLP, HBS, GLS, LabGCP, ISO 17025, CLIA including strategyAudit * Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits. * Participate in and may lead directed (For Cause) audits. * Works with contract personnel or consultants to prepare, conduct and report outsourced audits * Supports Due Diligence activities as assigned * Leads Supplier qualification activities (Operational Due diligence ODD) as assigned * Identify and assess gaps during supplier qualification assessmentsCAPA * Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completionInspection * Provides QA oversight and/or management of regulatory GxP inspections * Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.General Accountabilities * Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines * Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits * Communicates effectively with QA colleagues and business stakeholders * Maintains knowledge of relevant industry information affecting quality and compliance arena * Leads training for colleagues and business stakeholders as required. * Involved in and may lead the development and/or revision of QA processes, projects and tools * Provides general support related to regulatory authority inspections as and when required * Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert * Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations * Travel expectedREQUIRMENTS: * Degree level education or equivalent experience * Experience in pharmaceuticals or a related industry * Excellent analytical, written and oral communications skills * Fluent in written and spoken English * High ethical standards, trustworthy, operating with absolute discretion * Strong collaborative, influencing and interpersonal * skills – curious to understand business environment * Skilled at managing & using technology * Ability to maintain and create professional networks with stakeholders * Supplier qualification
企業(yè)簡介
阿斯利康是全球領先制藥公司,由前瑞典阿斯特拉公司和前英國捷利康公司于1999年合并而成。阿斯利康在6大治療領域為患者提供富于創(chuàng)新,卓有成效的醫(yī)藥產品,包括消化、心血管、腫瘤、中樞神經(jīng)、麻醉和呼吸等,其中許多產品居于世界領先地位。
阿斯利康總部位于英國倫敦,研發(fā)總部位于瑞典。產品銷售覆蓋全球100多個國家和地區(qū)。2005年公司銷售收入為240億美元。
阿斯利康擁有強大的研發(fā)能力,平均每個工作日的研發(fā)投入達到1400萬美元 (2005年研發(fā)總投入為34億美元)。我們在7個國家設有11個研發(fā)機構,共有11,900名員工從事與新藥研發(fā)相關的工作。
阿斯利康擁有極具希望的早期開發(fā)產品組合,共有45個項目處于臨床前研究階段、17個項目處于一期臨床研究階段、13個項目處于二期臨床研究階段、6個項目處于三期臨床研究階段。
阿斯利康在全球19個國家有27個生產基地,共有14,000名員工致力于為客戶提供安全、有效、高質量的產品。
阿斯利康在全球共有65,000名員工,從事醫(yī)藥產品和醫(yī)療服務的研發(fā)、生產和銷售業(yè)務。
阿斯利康被列入道瓊斯可持續(xù)發(fā)展指數(shù)(全球)以及顯示企業(yè)良好社會責任度的富時社會責任指數(shù)(FTSE4Good Index)。
上海相關職位: 銷售主管 銷售技術支持 工藝員 微生物檢驗員 維系保養(yǎng)員/電工 (MJ002499) QA體系專員 驗證專員/主管 QC化學分析員 (MJ002498) QA質量管理員(體系/驗證/注冊)
熱門區(qū)域招聘: 重慶 北京 上海 浙江 江蘇 廣東 山東 湖南 安徽 河北
上海招聘企業(yè): 上海華茂藥業(yè)有限公司 上海信誼藥廠有限公司 上海強生制藥 歐姆龍健康醫(yī)療(中國)有限公司 青海瑞成藥業(yè)(集團)有限公司 上海交通大學醫(yī)學院附屬瑞金醫(yī)院 復旦大學附屬中山醫(yī)院 上海復星醫(yī)藥 上海醫(yī)藥集團 上海脈啟科技有限公司
職位發(fā)布日期: 2023-05-18