Assistant manager
sanofi
مجموع سنوات الخبرة :9 years, 7 أشهر
• Experienced FDA Approved Tablet Manufacturing Expert with in- depth & valuable experience in all aspects related to production viz. scheduling and implementing production activities. Presently working as a Assistant manager - Production Manufacturing of Sanofi India Pvt. Ltd
• Proficient in manufacturing of various drugs and different formulations like Tablets, Capsules, Pellets with excellent strategic planning and resource management, quality control, technical troubleshooting, workforce supervision and customer relationship management processes.
• Significant understanding of all aspects governing operational and production activities and up to date knowledge of latest technological advancements, regulations/ guidelines & statutory compliances in the industry.
• Possess good knowledge of cGMP regulations..
• Well versed with GMP documentation like Daily logs books, log cards & exposed to various audits like USFDA, MHRA, MCA, TGA, GQA, ANVISA.
• Monitoring and calculation of Compression and packing OEE.
• Monitoring and calculation of Compression and packing PCT.
• Order and maintain inventory of machine change parts.
• Possess good knowledge of wuster technique.
• Handling deviation, Investigation and change control.
• Conducting SMED workshop, VSM, 5s activities, TPM Completed RED belt programme.
• Making common pack size to ensure low change over time on both primary and secondary packing
• . Preparation and execution of Qualification documents. (URS, DQ, Risk assessment, IQ, OQ, PQ & Area or Facility Qualification).