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.