RD Officer

Job description

- Make an overall plan for a whole product development process. - Study and translate technical documents related to a specific product development. - Refer to information of reference product (innovator or branded product) and propose specifications for raw materials and finished product (if needed). - Request QC department to establish specifications and/or analytical procedures for raw materials and finished product; request QV department to execute analytical method validation (if needed). - Prepare protocol for a development process for each specific product. - Request L&P department to provide raw materials (APIs, excipients, packaging materials) needed for the product development process as per the proposed specifications. - Request QC department to perform testing of raw materials for production of trial and scale-up batches. - Prepare manufacturing process for trial and scale-up batches. - Cooperate closely with other departments to schedule and execute trial batches, scale-up batches and formulation optimization as per the established protocol. - Request QC department to perform testing of finished product, comparative dissolution profiles and stability study including stress testing. - Prepare manufacturing process for pilot scale batches. - Cooperate with QV department to prepare manufacturing process validation protocol for pilot scale batches. - Join in manufacturing process validation on pilot batches. - Cooperate with QV department to prepare manufacturing process report on pilot batches. - Request QC department to perform testing of finished product, comparative dissolution profiles and BE study (where required), stability study. - Perform an overall evaluation of the project from trial batches till pilot batches until a confirmation of a success is obtained. - Prepare manufacturing process and manufacturing process validation protocol for production batches. - Write completely pharmaceutical development section for the submission for product registration under the guidance of RA Manager. - Provide RA staffs with documentation and the study data for product registration. - Transfer the manufacturing process from pilot batches to production batches with the assistance of other departments. - Involved in the investigation of causes and deal with problems during the transfer of manufacturing process to production. - Improve formulation and manufacturing process (where needed). - Update the specialist knowledge, current requirements, regulation and guidelines. - Perform any other tasks as per assigned by RA Manager. - Prepare weekly, monthly and quarterly reports on the project progress.