Assistant Manager
Current● Effectively handling the Life Cycle Management changes like change of API supplier, change of primary packaging materials suppliers, increase in the batch size, change in manufacturing line, etc. ● Acting as a point of contact (POC) for technology transfer and site transfer activities, transferred Gland Dundigal products to Gland Pashamylaram.● Preparation of Project Scope or Approach document / Manufacturing guidelines for Tech Transfer projects.● Arrangement of CFT meeting to monitor project status, to discuss Technical Constraints and further requirements of the project.● Budget preparation for ‘Site Transfer’ and ‘Technology Transfer’ projects.● Proficiency in the appliance of Import license, Test-License for new projects.● Proficiency in the initiation of Item Codes for API, Excipients & Primary Packing Materials.● To Co-Ordinate with the Purchase, Commercial and sourcing team getting the MOQ and Price Quote for Raw Material, Primary Packing Material for Budget Preparation.● Supporting and Co-ordination with SCM during procurement of indented items.● Arrangement of API, Excipients, Standards, and Impurities for Preliminary evaluation of Project Development.● Follow up with QC for Sampling, analysis, and release of Raw Materials, Packing Materials, and Consumables that are required for batch execution.● Conducting the KICK-OFF meeting and preparation of project timelines for new projects.● Allotment of Project Identification Code for new projects as per SOP.● Preparation and review of change controls, Deviation’s, BPCR, Stability protocols, Submission batch protocols, Sampling schedule & stability report related to TT. ● Follow-up and readiness of Batch Records which is required Submission Batches.● Slot request for PPIC execution of Process Optimization Batches and Submission Batches.● Supporting and Co-Ordination with Regulatory Team for ANDA Dossier filing.
