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.
Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
Execute the finished product stability testing, and initial the relevant stability reports.
Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
Initial and revise the protocol of method transfer and validation for chemical testings;
Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
Report the OOS results, and conduct laboratory investigation per line manager instruction;
Provide specific information when communicating with government drug testing agencies;
Responsible for the safety, health and environmental protection (EHS) of itself position;
Complete other tasks assigned by line manager.
Qualification and Experience
College degree or above in pharmacy relevant major;
2 years of relevant work experience;
With good physical and chemical testing skills and knowledge;
Familiar with chemical laboratory procedures， laboratory instrument operation and regulatory requirements;
Experience with chemical method validation is preferred;