職責(zé) Responsibility：
1. 負(fù)責(zé)供應(yīng)商質(zhì)量管理團(tuán)隊(duì)的日常管理
Responsible for the daily management of the Supplier Quality Management team.
2. 帶領(lǐng)團(tuán)隊(duì)完善和優(yōu)化各類供應(yīng)商管理的質(zhì)量管理體系，確保供應(yīng)商質(zhì)量管理符合GMP和相關(guān)法規(guī)要求；
Lead the team in improving and optimizing quality management systems for supplier management, ensuring compliance with GMP and relevant regulations.
3. 負(fù)責(zé)供應(yīng)商的資質(zhì)評(píng)估、供應(yīng)商資質(zhì)維護(hù)，落實(shí)日常管理工作；
Conduct supplier qualification assessments, maintain qualification records, and carry out daily management.
4. 根據(jù)物料風(fēng)險(xiǎn)和供應(yīng)商風(fēng)險(xiǎn)，制定供應(yīng)商年度審計(jì)計(jì)劃，并對(duì)供應(yīng)商質(zhì)量體系、質(zhì)量文件、質(zhì)量控制執(zhí)行的符合性進(jìn)行評(píng)估；
Develop annual supplier audit plans based on material and supplier risks, and evaluate the compliance of suppliers' quality systems, documents, and quality control implementation.
5. 負(fù)責(zé)處理與供應(yīng)商相關(guān)的異常事件的內(nèi)外部溝通與跟蹤，監(jiān)督供應(yīng)商質(zhì)量相關(guān)的整改，指導(dǎo)/參與供應(yīng)商整改的跟蹤直至閉環(huán)，以及內(nèi)部解讀供應(yīng)商提供的回復(fù)和報(bào)告；
Handle internal and external communication and follow-up on supplier-related deviations, oversee the implementation of supplier quality corrective actions, guide/participate in tracking supplier corrective actions until closure, and internally interpret responses and reports provided by suppliers.
6. 負(fù)責(zé)完成供應(yīng)商質(zhì)量績效的管理，對(duì)供應(yīng)商質(zhì)量周報(bào)/月報(bào)/季報(bào)/年報(bào)進(jìn)行統(tǒng)計(jì)分析，定期組織召開供應(yīng)商管理分析，持續(xù)監(jiān)控供應(yīng)商質(zhì)量管理水平；
Manage supplier quality performance by conducting statistical analysis of supplier quality weekly/monthly/quarterly/annual reports, organize regular supplier management review meetings, and continuously monitor supplier quality management levels.
7.能夠獨(dú)立負(fù)責(zé)供應(yīng)商質(zhì)量審計(jì)，包括審計(jì)準(zhǔn)備、審計(jì)組織和執(zhí)行，以及審計(jì)后整改跟蹤。
Independently conduct supplier quality audits, including audit preparation, organization, execution, and post-audit corrective action follow-up.
任職要求：
Requirements:
1. 藥學(xué)相關(guān)專業(yè)，本科及以上學(xué)歷；
Educational Background in Pharmacy or related discipline, with a Bachelor's degree or above.
2. 好的GMP藥品質(zhì)量和生產(chǎn)經(jīng)驗(yàn)，具有6年以上供應(yīng)商質(zhì)量管理經(jīng)驗(yàn)；
Solid experience in GMP pharmaceutical quality and production, with at least 6 years of experience in supplier quality management.
3. 熟悉原輔包相關(guān)物料的現(xiàn)場監(jiān)控及質(zhì)量體系評(píng)審等工具及方法；
Familiar with on-site monitoring and quality system audit tools/methods for materials related to raw materials, excipients, and packaging.
4. 具有獨(dú)立解決問題的能力，原則性強(qiáng)，具備良好的內(nèi)外部溝通和協(xié)調(diào)能力；
Strong problem-solving skills, adherence to principles, and excellent internal and external communication and coordination abilities.
5. 具有良好的數(shù)據(jù)分析能力，可以從不同維度和角度分析總結(jié)數(shù)據(jù)；
Proficient in data analysis, capable of analyzing and summarizing data from different dimensions and perspectives.
6.良好的英文聽說讀寫能力。
Good English listening, speaking, reading, and writing skills.