Industrial Developement Manager
hydrapharm
مجموع سنوات الخبرة :14 years, 5 أشهر
Organization, planning and monitoring the progress of the different stages of industrial development projects
• Proposal of new equipment, technologies, forms and methods of adaptation to sites and existing equipment
• Collaboration with strategic partners and external service providers in developing projects
• Arbitration and allocation of resources (human, financial, time, materials ...) according to the development strategy
• Coordination and control of the manufacture pilot batches (implementation process)
• Organization and coaching ndustrial development teams
• Coordination of activities with other services
• Development of specifications for suppliers or external service providers
• Monitoring the application of the rules on production, quality and hygiene and safety and environment
• Proposal and implementation of actions aimed at continuous improvement of existing processes
approve all technical documentation
ensure developement and registration of new products
ensure the production, control and release of industrial batches of products with marketing authorization
manage the technical managers (quality control, production, regulatory, , supply, maintenance and quality assurance)
Regulatory aspect
Submission file, declaration and customs clearance authorization, Trademark Protection. repayment dossier, art work validation , release dossier, warehouses statement, import program
Quality system
Mastery and continuous improvement of an approved Quality system (quality agreement, audit report and CAPA assessment)
Document management
Management of master documents ( quality manual, VMP, product annual quality review, Guidance for Preparing Standard Operating Procedures
Quality SOP
Management and application of SOP (training, change control, deviation, CAPA, self inspection, out of specification results)
Qualification Perform request for proposal and machines specification, FAT /SAT and equipment qualification. monitoring of annual program
Metrology
Define maximum permissible error
Validation
raw material supplier agreement, purified water, cleaning, analytical methods &process validation
Technical aspect
Mastery of technical dossier(CTD format), management and accomplishment of analytical transfer, control methods, manufacturing and packaging process validation and shelf life studies
differente laboratories (pharmacologie/toxicologie/parasitologie/microbiologie/hematologie/galenique/biochimie)
Human Resource Management, Business Law, fundamental marketing, math finance, French technique, technical English, Corporate Taxation, Economic Environment, Business Strategy, General Accounting, Cost Accounting Technical Trading
diplôme d’État en pharmacie
mention bien