Syngene looking for Associate Manager - PPIC | M.Pharm, M.Sc
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.
Post : Associate Manager - PPIC (Biologics)
Job Purpose : The objective of this role is to ensure Inventory Control (Material Management) at optimum levels to facilitate timely execution of manufacturing activities as per the business plan within Syngene's Bio-pharmaceutical Manufacturing Plants including but not limited to procurement, tracking the receipt & release of the materials, maintenance of stocks at optimum levels, track and ensure timely retesting, and timely disposition of unused stocks (expired materials/ leftover from closed projects)
• Perform timely initiation of material procurement, receipt, testing and/or release for manufacturing activities.
• Perform timely reporting of deviations, appropriate investigations to identify the root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence for Material Management.
• Perform Inventory Management for Biologics Operations covering the following elements
• Optimum levels as per the requirements and lead times for the procurement, receipt, and release.
• Exigency plans for materials with long lead times or short expiry
• Perform on-time extension requests before the due date for any QMS documents like Change Control, Deviation, CAPA related to Material Management and whenever the closure is not expected by the proposed target dates.
• Participate in the project review meetings for Biopharmaceutical manufacturing.
• Support for determining material requirements for the new projects with the help of technical teams (MSAT and Manufacturing) and ensure availability as per the project plan.
• Support for preparation of the production schedule in consultation with the relevant stakeholders and share the same with all the relevant functions on a regular basis.
• Support for ensuring completion of following activities for the new projects/ products:
• Product code creation in SAP (MDG) including BOM and inspection lot creation
• Mapping with the relevant plant and project codes
• Support to ensure tracking of manufacturing activities against the schedule to ensure adherence to plan, and report/escalate any challenges to the management.
• Perform and/or ensure the following activities:
• Creation of Process Order for batch execution
• Issuance of Material Requisition (MRN) Note for the batch processing
• Stock posting for the process intermediates and final products
• Timely return and posting of unused quantities of the issued materials.
• Support to ensure timely tracking of Operational Metrics for Manufacturing Operations and management reporting.
• Support to facilitate the timely batch release by coordinating with the relevant stakeholders (Manufacturing, QC and QA, etc.).
• Support to facilitate the timely dispatches as per the plan and/or clients' requests.
• Support to ensure timely execution and closure of GMP documentation related to material management.
• Track and ensure implementation of Operational Excellence initiatives for Biologics Operations.
• Perform periodic review of inventory for ensuring material availability for all the ongoing projects.
M.Sc with 11 years/ M.Pharma with more than 9 years
Qualification : M.Sc, M.Pharma
Location : Bangalore, India
Industry Type : Pharma/ Healthcare/ Clinical research
Req Id : 6329
End Date : 30th December, 2019
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