Tekirdağ, Türkiye
I worked in pharma industry about 14 years with experienced in Pilot Production, Formulation Development and Process Development, Product Portfoilo Management of Drug Products with guidance of GMP and GLP. I have good experienced for Patex Launch productions for Generic products.
Responsibilities: • To execute and coordinate the technical transfer studies for contract manufacturing products which will be produced and to ensure transfer completely. • To execute the technological changes works (trial works, pilot production etc) for current products and ensures preparing required documents for registration. • To perform and participate to studies about product variatons, or developing primer packaging material (eg. package, bottle, cover) functions for use in production, and decreasing the costs of products • To execute the development and improvement studies upon the production methods of marketed Sanofi products. • To Perform required trial works for alternative supplier related to raw materials of the products currently in production and ensures preparing required documents for the variation • To execute and coordinate all the Process Validation and revalidation studies of all products in production • To participate in Internal and External audits for the topics concerning own departments and to ensure preparation of required • To answer the questions coming from authorities and Ministry, about the products in scope of portfolio maintenance in his responsibility • Coordination of robustness projects in line with procedures • Leading of robustness and process improvement projects and team management Coordination of robustness project actions between the production and quality department
Responsibilities: · Screening, pre formulation and development of solid, semi-solid and liquid dosage forms, Extended or Immediate release tablets, Antimicrobial drugs, Immunosuppressant capsules, DPP-4 inhibitors, Antiretrovirals and etc. · Scale up and optimization of production processes including combination of drug products with QbD approach. · Pilot and commercial batches production and validation. · Leading first launch productions with coordinating other departments. · Leading technology transfer and and process optimization of commercial drug products with coordinating other departments. · Manufacturing process robustness improvement projects of commercial drug products to solve problems occur during production, stability process for produced licensed new products. · Conduction of bioequivalence studies. · Playing an active role during Authority and Customer Audit For Formulation Development Department. · Leading Change Management Projects and follow up CAPA actions and investigate the root cause of OOT or OOS. · Preparing Risk Assessment report for CMC Regulatory guidance for products. · Following patent applications and TEYDEB projects. · Managing relations with government and prepare yearly R&D · Centre Report · Creating bill of materials for Pilot production in SAP. Following all processes in SAP throughout the production. · Creating the purchase demand of excipient and API in SAP and follow up with Supply chain Dept. for Warehouse management for Development materials in SAP. · Preparing CTD dossier for new product and transfer product / API (parts of 3.2.P.3, 3.2.P.4, 3.2.P.5, 3.2.P.6, 3.2.P.8) · Answering Deficiency Letter for new and transfer product during Product License Application · Playing an active role during internal and external audits
Responsibilities: · To organize scale up pilot production equipments which will be utilized for new product development (solid, liquid and semi solid dosage forms) and Co-development studies. · To keep Formulation Development Laboratory and Pilot Production Area ready for all internal and external audits. · To prepare the technical documents related to scale up / pilot production area wihich are essential for technical dossier. · To determine the equipments required to be purchased next year and execute plannings.