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Immacule Lifesciences
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  • Plant Head - Operations (Injectable)  

    - Not Specified
    Job PurposeLead and manage overall site operations for the Injectable... Read More

    Job Purpose

    Lead and manage overall site operations for the Injectable Manufacturing Facility, ensuring excellence in Manufacturing, Packaging, Warehouse, PPIC, Engineering, Compliance, Quality, Safety, and Business Performance.


    Key Responsibilities

    Drive overall plant performance and ensure achievement of production, quality, compliance, delivery, and business targets.Oversee Manufacturing, Packaging, Warehouse, PPIC (Production Planning & Inventory Control), and Engineering operations.Ensure effective production planning, material availability, inventory optimization, and on-time customer deliveries.Provide strategic and operational leadership to ensure efficient site operations and optimum resource utilization.Coordinate with Project Management teams on plant expansion, technology upgrades, and critical projects.Collaborate with R&D for technology transfer, scale-up, validation, and commercialization activities.Ensure compliance with cGMP requirements and maintain audit readiness for global regulatory agencies, including USFDA.Lead client visits, customer audits, and regulatory inspections.Work closely with QA, QC, Supply Chain, Engineering, and other cross-functional teams to achieve organizational objectives.Manage budgets, operational costs, and capital expenditure plans.Drive continuous improvement, productivity enhancement, cost optimization, and operational excellence initiatives.Develop high-performing teams and foster a culture of accountability, compliance, quality, and safety.


    Qualifications & Experience

    Bachelor's/Master's degree in Pharmacy, Engineering, or related discipline.20+ years of experience in pharmaceutical manufacturing, with significant exposure to Sterile/Injectable Operations.Proven experience in leading large-scale manufacturing facilities with responsibility for end-to-end plant operations.Strong exposure to global regulatory audits, including USFDA, MHRA, EU GMP, and other international agencies.


    Key Competencies

    Plant LeadershipInjectable Manufacturing OperationsPPIC & Supply Chain ManagementRegulatory ComplianceProject ManagementStrategic PlanningBudget & Resource ManagementStakeholder ManagementTeam Development & Leadership

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  • Assistant Manager - PPIC & Purchase (Injectables)  

    - Not Specified
    Job PurposeTo manage procurement, material planning, vendor coordinati... Read More

    Job Purpose


    To manage procurement, material planning, vendor coordination, and inventory support for sterile injectable manufacturing operations while ensuring timely availability of raw materials and packaging materials in compliance with quality and regulatory requirements.


    Key Responsibilities

    Responsible for sourcing and procurement of APIs, excipients, and packaging materials.Develop and evaluate vendors as per approved vendor qualification procedures and QA systems.Float enquiries, obtain quotations, negotiate commercials, and finalize suppliers for required materials.Follow up with Regulatory Affairs (RA) for timely response and approval of procurement-related queries.Prepare and process purchase orders for raw and packaging materials.Coordinate with vendors for timely dispatch and delivery of materials.Ensure uninterrupted availability of RM/PM as per production planning requirements.Coordinate with Production, QC, QA, Warehouse, and SCM teams for smooth material flow and plant operations.Coordinate with QC for release of raw materials, packaging materials, and finished products.Coordinate with Accounts for invoice verification and payment processing.Arrange vendor qualification documents and support vendor audit activities.Coordinate sample procurement for F&D and ARD for new vendor evaluation.Ensure execution of Quality Agreements and Technical Agreements with vendors.Prepare raw material cost estimations for new product/projects.Monitor inventory status and support material planning activities to avoid shortages or excess inventory.Ensure compliance with cGMP, GDP, and company procurement procedures.


    Qualifications

    B.Pharm / M.Pharm / MBA (Supply Chain) / Graduate in relevant discipline.


    Experience

    8-12 years of experience in PPIC, procurement, or supply chain functions in pharmaceutical sterile/injectable manufacturing.


    Key Skills

    Procurement & Vendor ManagementPPIC & Material PlanningPharmaceutical Supply Chain OperationsVendor Qualification & Audit CoordinationInventory ManagementCommercial NegotiationERP/SAP KnowledgeCross-functional CoordinationcGMP & Regulatory ComplianceCommunication & Analytical Skills

    Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany