
Lead Manufacturing Operations
4 days ago
Key Leadership Roles:
- Strategic Direction: Provide leadership in driving operational excellence, ensuring alignment with regulatory requirements, cGMP, EHS & Quality standards.
Responsibilities:
Operational PlanningDevelop and execute operational plans to optimize resource utilization (material, labor & overheads) and ensure efficient production processes.
Compliance ManagementEnsure products meet Abbott policies, EHS standards, regulatory requirements, and cGMP through effective compliance management strategies.
Labor Laws and SecurityMaintain compliance with labor laws, security standing orders, and code of business conduct to ensure a safe working environment.
Resource ProvisionEnsure provision of necessary resources (area, equipment, workforce) for quality production.
Training and DevelopmentFoster initial and continuing training of production personnel, including GMP training, to enhance skills and adapt to changing needs.
Mfg Technology and EquipmentDrive strategic direction in Mfg technology and equipment maintenance, calibrations, and process validation.
Quality CoordinationCollaborate with Quality on QA audits, CAPA, Complaints, ERs, Market Returns, and Trend Analysis Reports to ensure quality excellence.
Problem ResolutionResolve quality problems in collaboration with QA, Regulatory, Technical Centre, Engineering, and Supply Chain to maintain uninterrupted product deliveries.
Budgeting and Master SchedulingPrepare the Plant annual budget in consultation with Finance and create a Master Schedule that directs all manufacturing, purchasing, and engineering activities.
KPI MonitoringMonitor KPIs and perform Root Cause Analysis where applicable to drive continuous improvement.
Document ReviewReview and approve technical documents, including SOPs, Manufacturing and Finishing Directions, in-process controls, Shop Orders, Validation documents, Change requests, CAPA, and ERs.
Production RecordsEnsure production records are reviewed and signed before being made available to the Quality Assurance department.
New Product RegistrationReview new product dossiers and Manufacturing input for product registration/re-registration submission to the Regulatory Department.
Batch Variance/Yield ReportsReview batch variance/yield reports with production managers and take appropriate steps for improvement.
Non-Value ActivitiesIdentify, prioritize, and stimulate the reduction or elimination of non-value-added activities to improve efficiency.
Employee DevelopmentFoster employee development, goal setting, performance assessment, and succession planning within the department.
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