資深質量保證專員

崗位職責:
Responsibilities:?
工作職責
GMP?regulatory?compliance?and?quality?related?submission?approval,?maintain?and?renew?manufacturing?license,?coordinate?Mock?recall,?authority?sampling.
GMP法規合規性、質量相關備案申報。藥品生產許可證照維持和更新。協調模擬召回、質量抽樣。
Be?responsible?for?Change?control?management,?organize?related?department?to?evaluate?the?risk?of?change?control?and?follow?up?the?implementation.
負責變更管理，組織各相關部門評估變更風險及后續執行的相關工作。
Organize?and?coordinate?audit?(external?and?internal)?and?follow?up?for?the?audit?findings?that?received
組織協調內外審和審計結果進行后續跟蹤。
Be?responsible?for?suppliers?management,?supplier?audit,?supplier?complaint,?QA?agreement??
負責供應商管理審計、供應商投訴、質量協議及。
Be?responsible?for?monthly?products?release?plan,?batch?record?review,?CoA?,?CoC?and?archiving?.
負責月度產品放行計劃、批記錄審核、檢驗報告，符合性說明發放和歸檔。
Coordinate?and?compile?relevant?QA/QC/PD/FE?to?fulfill?APR.
協調質量保證、質量控制、生產部、設備部匯總完成年度質量回顧工作。
Participate?in?site?self-?inspection.
參與工廠GMP自檢。
Revise?the?relevant?SOPs?to?ensure?operations?conform?to?SOPs.
根據GMP要求和實際日常工作情況及時更新相關sop，確保操作與sop一致。
Participate?in?completing?job?related?APR,?monthly?/QMR/Dashboard?report.
參與完成工作相關的年度質量回顧報告、各種相關月報。
Revise?the?relevant?SOPs?to?ensure?operations?conform?to?SOPs.
根據GMP要求和實際日常工作情況及時更新相關sop，確保操作與sop一致。
If?necessary?should?undertake?other?work?of?QA?team.
必要時，應承擔QA團隊其他工作。
Aware?of?and?comply?with?the?corporate?and?local?Quality/EHS?Manual,?Quality/EHS?Management?System,?Quality/EHS?Management?Policy,?Quality/EHS?Goals,?and?applicable?laws?and?regulations?as?they?apply?to?this?job?type/position.
關注和遵守公司要求的質量、環境健康手冊、管理體系和管理政策、目標和該職位的相關的法規要求。
Other?work?assigned?by?superior.
上級領導交代的其他工作。
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任職資格:
Main?INTERFACES:?
PD生產部、FE設備部、SC物流部、QC及工廠其他部門
Qualifications?(Knowledge,?Skills,?Competencies?&?Expectations):?
資質要求（知識、技能、能力&期望）
Knowledge:
知識
Bachelor?degree?or?above,?major?in?chemistry,?pharmaceutical,?microbiology?related.
大學本科或以上學歷，化學、藥學或生物相關專業優先。
Over?3?years?relevant?work?experience?in?pharmaceutical?manufacture?industry,?produce?injection?experience?is?a?plus.
3年以上醫藥行業相關工作經驗，有注射劑領域的質量經驗優先考慮。
Soft?Skills/Competencies:
技能/能力
Good?team?work?and?communication?skills.
良好的團隊合作精神和溝通能力；
Hard?Skills:
硬性技能
Good?English?skills?(especially?for?reading?and?writing).
良好的英語讀寫能力。
Expectations:
期望
Sense?of?responsibility,?diligent?and?with?high?integrity，Team-work?approach.
有責任心、勤奮、正直、誠信，具有團隊合作精神；
Strictly?comply?with?National?laws?and?regulations,?abide?by?the?company?Code?of?Conduct,?rules?and?regulations.?Ensure?that?all?work?behavior?conform?to?company's?compliance?requirements.
嚴格遵守國家法律法規，遵守公司員工行為準則和各項規章制度，確保所有的工作行為符合公司的合規要求。
Attendance?rate?is?no?less?than?90%?during?the?probation?period.
試用期期間出勤率不低于90%。