QMS專家
面議
工作性質(zhì)全職
職位類別其他職位
招聘人數(shù)1人
學(xué)歷要求本科
工作經(jīng)驗(yàn)5-10年
性別要求女
用工形式不限
技能等級(jí)
年齡要求不限
試用期無
工作地點(diǎn)江蘇省/泰州市
職位描述
崗位職責(zé)
1. Participate in the establishment, operation and improvement
of GMP systems of the company.
參與公司 GMP 質(zhì)量體系的建立、運(yùn)行及完善
2. Responsible for obtaining all kinds of drug
management and related laws, regulations and technical requirements, and archive
management and notification management
負(fù)責(zé)獲得各類藥品管理及相關(guān)法律、法規(guī)和技術(shù)要求，并作歸檔管理和通報(bào)管理
3. Participate in complain, self-inspection of
quality management system to ensure its effective operation
參與質(zhì)量管理體系自檢、投訴等，確保其有效運(yùn)行
4. Preparation, review, revision and management of
GMP documents of the department including SOPs, Protocols, reports,
investigation, Etc
參與本部門 GMP 文件的編制、審核、修訂和管理工作
5. Responsible for reviewing SOP prepared by each
department
負(fù)責(zé)審核各部門起草的 SOP
6. Responsible for perform investigations,
****uations and management of quality notifications such as deviation, CAPA,
Market compliments, FAR, OOS/OOT change controls etc
負(fù)責(zé)事件調(diào)查及評(píng)估，偏差， CAPA ，市場(chǎng)投訴， FRA,OOS/OOT 等等相關(guān)質(zhì)量的管理
7. Participate in preparing, reviewing and revising
Specification, Standard Test Procedures and General Test Procedures
參與質(zhì)量標(biāo)準(zhǔn)、標(biāo)準(zhǔn)檢驗(yàn)規(guī)程、通用檢驗(yàn)規(guī)程的起草、審核和修訂
8. Participate in validation and qualification
related work, such as preparing protocol and reports, implementation and
monitoring of plans, etc.
參與驗(yàn)證與確認(rèn)相關(guān)工作，比如方案和報(bào)告的起草、方案的實(shí)施和跟蹤等
9. Responsible for Supplier/Vendor qualification.
Supplier site audits where required.
負(fù)責(zé)供應(yīng)商資質(zhì)確認(rèn)
10. Responsible for retention samples management,
including daily management of retention samples room
負(fù)責(zé)留樣管理，包括留樣間的日常管理
11. Responsible for the check of laboratory test
data
負(fù)責(zé)實(shí)驗(yàn)室檢測(cè)數(shù)據(jù)的審核
任職要求
1. Bachelor
degree or above, major in pharmacy or related
本科及以上學(xué)歷，藥學(xué)或相關(guān)專業(yè)
2. Good command on English in listening, speaking,
reading and writing, English can be used as working language
英語聽、說、讀、寫能力強(qiáng)，英語可以作為工作語言
3. At least 8 years working experience in
pharmaceutical industry; at least 5 years QA team management experience, GMP
certification, familiar with GMP related specifications; familiar with FDA
certification management skills is preferred
8年以上制藥行業(yè)相關(guān)工作經(jīng)驗(yàn) ; 5 年以上 QA 團(tuán)隊(duì)管理經(jīng)驗(yàn)，參加過 GMP 認(rèn)證，熟悉 GMP 相關(guān)規(guī)范；熟悉 FDA 認(rèn)證相關(guān)管理技能者優(yōu)先
4. Have a strong sense of responsibility and team
spirit, good interpersonal communication, coordination and communication skills
有較強(qiáng)的責(zé)任心和團(tuán)隊(duì)精神、良好的人際溝通、協(xié)調(diào)和交往能力
