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.
在质量保证经理的领导下，作为上海新工厂QA部门放行高级主管/主管，带领团队，执行放行工作。
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.
负责并组织对原辅料、包装材料的放行以及成品放行前的质量审核，确保原辅料、包装材料、中间产品、待包装产品和成品符合质量标准。
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.
负责物料管理相关 SOP、取样计划、 COA 报告的审核，支持物料相关变更和验证活动；负责稳定性方案和报告的确认与审核。
Perform the annual product quality review.
执行产品质量年度回顾。
Create/review related QMS SOPs and records according to new requirements.
根据需要编写和审核相关质量体系文件和记录
Support internal and external audit.
协助公司内、外部审计工作。
Other duties as assigned by supervisor.
其他领导安排的工作。
职位所需的能力与经验
At least university degree, major in pharmaceutical, chemistry, biology or related subjects.
大学本科以上学历，药学、化学、生物学或相关专业。
Minimum 5 years of Release management working experience in pharmaceutical industry.
至少5年医药行业放行管理经验。
Experience in Quality control is preferred.
期望有质量控制工作经验。
Excellent communication, problem-solving, planning and organization skills.
良好的沟通、解决问题、计划和组织能力。
Good command of English, Good Computer skill.
良好的英语水平，良好的计算机技能。
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.