Oksana Ivanova
Director, Supply Chain/ Customer Service and Inside Sales @ Aspire Pharma
United States
Somerset
Pharmaceuticals
Sop, Quality Assurance, GMP, Pharmaceutical Industry, Validation, Product Development, Process Improvement, Quality Management, Manufacturing, R&D, Regulatory Affairs, Cross-functional Team Leadership, FDA, Pharmaceutics, Strategic Planning, Supply Chain Management, Operations Management, Inventory Management
Experience

Head of Planning / Operations / Customer Support
Somerset, NJ
• Planning and control all scheduling production activities. Balance production and inventory levels with demand to support target customer service levels, inventory turn goals and capacity utilization requirements. • Developing Sales & Operating Plan summaries for products including demand, inventory and production data. • Developing feasible, master production schedules for finished goods and component items based on capacity requirements. • Developing valid, feasible production schedules for finished goods and component items based on equipment, labor and raw material availability. • Lead of Customer support team • Managing customer complaints and coordinate with internal departments and resolve on time. • Working with key leaders namely Purchasing, Production, Quality/Regulatory, Maintenance and Finance. • Leading other projects and complete additional duties, as required/ assigned. • Ensure effective internal communication across the company. • Publish and perform root cause analysis on key metrics including Customer Service Level/ on time shipments, Actual vs. Scheduled Productions and Master Schedule Stability, Monthly materials adjustments and wastage adjustments, Monthly Inventory, Monthly Production data, Down time and M/C efficiency in encapsulation area (Plan v/s actual) Principle Relationships • Inside the Company - Manufacturing and Warehouse/Shipping; Maintenance Manager, Sales Managers, Director of Purchasing, Finance, Quality regulatory and Quality Control. • Outside the Company - Production Coordinators at packaging subcontractors; Sales Representatives; communication with customers. • Supervision – Warehousing, Logistics and Inventory staff

QA Manager
North Brunswick, NJ
• Lead and manage the facility Quality Assurance Department and personnel • Initiate, direct, control and report on quality assurance plans and projects assigned in a timely manner • Coordinate with Product Management, Research and Development and Manufacturing on the generation and update of product and process specifications • Coordinate with Manufacturing on ensuring compliance with GMPs • Assisting with customer and third party audits • Other duties deemed appropriate by the Director of Quality Assurance • Supervise record retention • Raw material qualification • Schedule and manage sample collection protocol for testing • Record incoming purchase orders for all products on production schedule • Issue production batch records • Ensure timely availability of raw materials for production • Review batch record for completion Audits • Ensure compliance to dietary supplement cGMP regulations
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