Medochemie Tuyển Dụng
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Mô tả công ty
Medochemie (Europe) là 1 Một trong những đơn vị cấp dưỡng dược phđộ ẩm Generic nhiều đất nước bậc nhất tại Châu Âu, xuất hiện trên 95 giang sơn bên trên nhân loại. Trong khi, Shop chúng tôi còn tồn tại Nhà lắp thêm Medochemie (Viễn Đông) đạt tiêu chuẩn chỉnh GMP-EU chăm chế tạo với xuất khẩu dược phẩm đặc trị tại VSIPhường. II và VSIP. II Msinh hoạt rộng lớn, Bình Dương
Xem thêm: Chế Độ Kế Toán Theo Quyết Định 48 /2006/Qđ, Quyết Định 48/2006/Qđ
- Make an overall plan for a whole sản phẩm development process.- Study & translate technical documents related lớn a specific product development.- Refer to lớn information of reference product (innovator or branded product) và propose specifications for raw materials và finished hàng hóa (if needed).- Request QC department khổng lồ establish specifications and/or analytical procedures for raw materials and finished product; request QV department khổng lồ exedễ thương analytical method validation (if needed).- Prepare protocol for a development process for each specific product.- Request L&P. department lớn provide raw materials (APIs, excipients, packaging materials) needed for the product development process as per the proposed specifications.- Request QC department lớn perkhung testing of raw materials for production of trial and scale-up batches.- Prepare manufacturing process for trial và scale-up batches.- Cooperate closely with other departments lớn schedule & exedễ thương trial batches, scale-up batches and formulation optimization as per the established protocol.- Request QC department to lớn perform testing of finished hàng hóa, comparative sầu dissolution profiles và stability study including căng thẳng testing.- Prepare manufacturing process for pilot scale batches.- Cooperate with QV department to lớn prepare manufacturing process validation protocol for pilot scale batches.- Join in manufacturing process validation on pilot batches.- Cooperate with QV department khổng lồ prepare manufacturing process report on pilot batches.- Request QC department khổng lồ perform testing of finished hàng hóa, comparative sầu dissolution profiles và BE study (where required), stability study.- Persize 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 & the study data for product registration.- Transfer the manufacturing process from pilot batches to lớn production batches with the assistance of other departments.- Involved in the investigation of causes and giảm giá with problems during the transfer of manufacturing process lớn production.- Improve sầu formulation và manufacturing process (where needed)- Update the specialist knowledge, current requirements, regulation and guidelines.
