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.
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.
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.
Create/review related QMS SOPs and records according to new requirements.
Support internal and external audit.
Other duties as assigned by supervisor.
At least university degree, major in pharmaceutical, chemistry, biology or related subjects.
Minimum 5 years of Release management working experience in pharmaceutical industry.
Experience in Quality control is preferred.
Excellent communication, problem-solving, planning and organization skills.
Good command of English, Good Computer skill.
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.