驗證主管崗位職責匯編(2篇)

崗位職責是什么

驗證主管是企業(yè)質量管理體系中的關鍵角色，負責確保產(chǎn)品或服務的質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，熟悉相關領域的質量標準和法規(guī)。

2. 精通驗證方法和流程，能設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，確保任務按時完成。

4. 嚴謹細致，對數(shù)據(jù)敏感，能準確分析驗證結果。

5. 良好的溝通技巧，能與各部門有效協(xié)作，解決質量問題。

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)或服務過程，確保其符合預設的驗證標準。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)務環(huán)境和法規(guī)要求。此外，他們還需要對新引入的技術、設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：分析驗證結果，識別改進點，推動質量管理體系的持續(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乎產(chǎn)品質量，更關乎企業(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、有固體制劑設備、公用系統(tǒng)確認經(jīng)驗

5、熟悉驗證過的主要設備原理。

6、懂計算機化系統(tǒng)驗證者優(yōu)先

7、具有基礎的制藥裝備自動化、應用軟件基礎知識。