Requirement for Sr.executive or Jr.Manager-PPIC

Job Description

Designation: Sr.executive or Jr.Manager-PPIC Job Location: Bengaluru, India Reporting to: Assistant General Manager, Pharmaceutical Development Operating Unit: Biopharmaceutical Department: Biopharmaceutical Operations The Company Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA. The Role The role is responsible for Production Planning and Inventory control, Material management and General Consumables procurement management Key Result Areas Role-specific: Primary Responsibility:
• Ensure material requirements for the new projects with the help of technical teams (MSAT and Manufacturing) and ensure availability as per the project plan.
• Prepare the production schedule in consultation with the relevant stakeholders and share the same with all the relevant functions on a regular basis.
• Ensure 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
• Lead and 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.
• Lead and ensure timely tracking of Operational Metrics for Manufacturing Operations and management reporting.
• Facilitate timely batch release by coordinating with the relevant stakeholders (Manufacturing, QC and QA, etc.).
• Facilitate timely dispatches as per the plan and/or clients requests.
• Lead and 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.
• 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.
Secondary Responsibilities:
• Support for timely initiation of material procurement, receipt, testing and/or release for manufacturing activities.
• Support for 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.
• Support for 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.
Education and Experience Masters/B.Tech with 6-9 years of relevant experience Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Please visit us at https://syngeneintl.com/ to know more about us and what we do. ,

Keyskills :
change controlmaterial procurementmaterial managementlegislative relationsinventory controlinventory managementroot cause