- 目錄
崗位職責是什么
驗證主管是企業(yè)質(zhì)量管理體系中的關(guān)鍵角色，負責確保產(chǎn)品或服務(wù)的質(zhì)量符合既定標準和法規(guī)要求，通過嚴謹?shù)尿炞C流程確保公司的運營效率和客戶滿意度。
崗位職責要求
1. 具備深厚的行業(yè)知識和實踐經(jīng)驗，熟悉相關(guān)領(lǐng)域的質(zhì)量標準和法規(guī)。
2. 精通驗證方法和流程，能設(shè)計并實施有效的驗證方案。
3. 具備出色的組織協(xié)調(diào)能力，能有效管理驗證團隊，確保任務(wù)按時完成。
4. 嚴謹細致，對數(shù)據(jù)敏感，能準確分析驗證結(jié)果。
5. 良好的溝通技巧，能與各部門有效協(xié)作，解決質(zhì)量問題。
6. 強烈的責任心和風險意識，能在問題出現(xiàn)時迅速采取應對措施。
崗位職責描述
驗證主管在日常工作中，需要監(jiān)控和評估生產(chǎn)或服務(wù)過程，確保其符合預設(shè)的驗證標準。他們需要制定和更新驗證計劃，確保其適應不斷變化的業(yè)務(wù)環(huán)境和法規(guī)要求。此外，他們還需要對新引入的技術(shù)、設(shè)備或流程進行嚴格驗證，以保證其安全性和有效性。
有哪些內(nèi)容
1. 驗證計劃與執(zhí)行：制定全面的驗證計劃，包括驗證范圍、目標、方法和時間表，并監(jiān)督執(zhí)行，確保計劃的順利完成。
2. 團隊管理：招募、培訓和指導驗證團隊成員，提升團隊的整體能力和效率。
3. 文件管理：維護驗證記錄，確保所有數(shù)據(jù)的準確性和完整性，以便于審計和追蹤。
4. 風險評估：識別潛在的質(zhì)量風險，制定預防和糾正措施，防止問題的發(fā)生。
5. 內(nèi)外部溝通：與內(nèi)部各部門、供應商及監(jiān)管機構(gòu)保持良好溝通，確保驗證活動符合各方期望。
6. 不斷改進：分析驗證結(jié)果，識別改進點，推動質(zhì)量管理體系的持續(xù)優(yōu)化。
7. 法規(guī)合規(guī)：跟蹤最新的法規(guī)動態(tài)，確保公司的驗證活動始終符合法律法規(guī)要求。
驗證主管的角色不僅關(guān)乎產(chǎn)品質(zhì)量，更關(guān)乎企業(yè)的聲譽和客戶信任。他們通過專業(yè)的驗證工作，為企業(yè)穩(wěn)定運營提供堅實保障，助力企業(yè)在競爭激烈的市場中贏得優(yōu)勢。
驗證主管崗位職責范文
第1篇 qc驗證主管崗位職責
qc validation/qualification supervisor儀器驗證主管 諾化仕(無錫)制藥有限公司 諾化仕(無錫)制藥有限公司,諾化仕,諾化仕 job summary:
?ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;
?support non-routine analytic activities such as analytical validation, analytical transfers and method troubleshooting;
?manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).
mains missions :
?maintenance/qualification of laboratory equipment ;
?management of analytical transfer and validations.
mission 1: maintenance
? organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs
? organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)
? manages stocks of spare parts needed for first-level maintenance
? represents the maintenance pole during audits and inspections by the authorities
? supports laboratory technicians in case of equipment problems
? organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies
mission 2: qualification laboratory equipment
? write the equipment qualification documentation for the laboratory (urs, protocols ....)
? organize qualification by suppliers
? conduct and / or organize additional tests not performed by suppliers (internal or outsourced)
? write the equipment usage documentation (operating modes, logbooks ...)
? presents qualification records during audits and inspections by the authorities
? ensures the training of technicians in the use of equipment
? organizes equipment supplier qualification
? participates in the choice of laboratory equipment and software
mission 3: coordination of analytical transfer, validations and troubleshooting activities
? supports the technicians in case of analytical problem, technical oos, technical question ? write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) ? organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)
? participates in the creation / modification of the working documentation (analytical methods, work instructions…
mission 4: laboratory life
? participates to various meetings related to the operation of the service (daily, monthly ...) ? leads actions to improve the operation of the maintenance center and the laboratory. ? defines with the manager the investment strategy for laboratory equipment ? is the system administrator of the labs si
required skills:
1. bachelor degree in relevant;
2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;
3. spoken english is a plus;
4. good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ich...);
5. good understanding of equipment and analytical laboratory techniques (titration, gc, hplc, spectroscopy, karl fischer, ....);
6. knowledge of software related to laboratory equipment.
第2篇 驗證主管崗位職責
驗證主管 安禮特(上海)醫(yī)藥科技有限公司 安禮特(上海)醫(yī)藥科技有限公司,安禮特 五、驗證主管1-2人
崗位職責
1、參與生產(chǎn)系統(tǒng)驗證,計算機化系統(tǒng)驗證項目實施
2、制定驗證總計劃/風險評估/設(shè)計文件/驗證文件/驗證報告/追溯矩陣文件
3、參與驗證過程中的偏差、變更處理。
崗位要求:
1、具有藥學相關(guān)專業(yè)本科以上學歷;
2、有參與建立驗證體系的經(jīng)驗。
3、制定過gmp驗證總計劃和驗證實施計劃。
4、有固體制劑設(shè)備、公用系統(tǒng)確認經(jīng)驗
5、熟悉驗證過的主要設(shè)備原理。
6、懂計算機化系統(tǒng)驗證者優(yōu)先
7、具有基礎(chǔ)的制藥裝備自動化、應用軟件基礎(chǔ)知識。
