Serve as the Release Sr. supervisor / supervisor in the Shanghai New Plant QA, lead the team to execute the release action under the leading of QA manager.
在質量保證經理的領導下，作為上海新工廠QA部門放行高級主管/主管，帶領團隊，執行放行工作。
Responsible for and organize the release of API, raw materials, packaging materials and the quality review before the release of finished products, to ensure that raw materials, packaging materials, intermediate products, products to be packaged and finished products meet the quality standards.
負責並組織對原輔料、包裝材料的放行以及成品放行前的質量審核，確保原輔料、包裝材料、中間產品、待包裝產品和成品符合質量標準。
Responsible for material management related SOP, sampling plan, COA report review, support material related changes and validation activities. Responsible for stability protocol and report review.
負責物料管理相關 SOP、取樣計劃、 COA 報告的審核，支持物料相關變更和驗證活動；負責穩定性方案和報告的確認與審核。
Perform the annual product quality review.
執行產品質量年度回顧。
Create/review related QMS SOPs and records according to new requirements.
根據需要編寫和審核相關質量體系文件和記錄
Support internal and external audit.
協助公司內、外部審計工作。
Other duties as assigned by supervisor.
其他領導安排的工作。
職位所需的能力與經驗
At least university degree, major in pharmaceutical, chemistry, biology or related subjects.
大學本科以上學歷，藥學、化學、生物學或相關專業。
Minimum 5 years of Release management working experience in pharmaceutical industry.
至少5年醫藥行業放行管理經驗。
Experience in Quality control is preferred.
期望有質量控制工作經驗。
Excellent communication, problem-solving, planning and organization skills.
良好的溝通、解決問題、計劃和組織能力。
Good command of English, Good Computer skill.
良好的英語水平，良好的計算機技能。
Participate in the work related to new product introduction and organize the drafting of R&D related contracts.
Perform process transfer, process validation and cleaning validation of new products, draft process documents (process flow documents and master batch record, etc.) prior to product commercialization.
Participate in product-related design work, including but not limited to: new equipment design, tablet/capsule appearance design, printed packaging material design, inner packaging layout design, etc..
Cooperate with the preparation of relevant documents for product registration.
Review the validation documents related to the process and cleaning such as revalidation, continued process verification, etc. after commercialization of the product; review the process documents of commercialized products.
Cooperate with deviation investigation and change impact assessment in the production process.
Cooperate with the work related to the declaration of high-tech enterprises. Apply for R&D related government subsidies.
Other R&D related matters.
Qualification and Experience
Bachelor degree or above, pharmacy related majors.
At least five years working experience in oral solid dosage.
Familiar with the technical transfer, process validation and cleaning verification/validation.