Medochemie

- 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.