Planning and Operational Excellence Manager

• Feb 2022 - Present

Planning and Operational Excellence Supervisor

• Jun 2020 - Feb 2022

Planning, scheduling and coordinating production plans based on material and capacity availability to meet domestic sales requirements and at the same time increase efficiency of the production lines. - Creating mid-term capacity planning / line loading forecast for all current and inquiry business. - Monitoring and controlling inventory to meet inventory targets. - Loading and maintaining the Master Production Schedule (MPS). - Running the planning process (MRP and manual) and ensuring planned requirements are accurate. - Updating and maintaining daily production status report. - Networking with key internal and external contacts, in particular development teams. - Analyzing Plant KPI`s (OEE, Balance Score Card, Benchmark, Quality Metrics) - Assure full deployment and efficient use of the Operating System, Management System, Mindset and Behaviors - Engage colleagues in the lean transformation in terms of mindset, behaviors and people capabilities - Use different tools and methods to analyze and improve production work (SMED, 6sigma, SQDCM) - Create a training and coaching program to build project management capabilities - Apply lean skills to improve line designs to improve safety, quality and efficiency - Enhance the management system of sites from Tier 1 to Tier 3 - Internal and External Audit of Companies for Machinery & Utilities Processes

Production Engineer

• Mar 2018 - May 2020

Planning, scheduling and coordinating production plans based on material and capacity availability to meet domestic sales requirements and at the same time increase efficiency of the production lines. - Creating mid-term capacity planning / line loading forecast for all current and inquiry business. - Monitoring and controlling inventory to meet inventory targets. - Loading and maintaining the Master Production Schedule (MPS). - Running the planning process (MRP and manual) and ensuring planned requirements are accurate. - Updating and maintaining daily production status report. - Networking with key internal and external contacts, in particular development teams. - Analyzing raw material balances and ensuring there are adequate levels. - Coordinating the release and shipment of product to the customer. - Managing delivery process of raw materials and packaging materials through effective communication with suppliers. - Planning and organizing related warehouse operations. - Being responsible for ERP system as a key user and providing the completion of necessary changes in collaboration with IT department. - Creating and updating master data in ERP system (route, recipe, material master data, etc.). - Internal and External Audit of Companies for Machinery & Utilities Processes - DQ, IQ, OQ, PQ - FAT, SAT - Installation & Start Up

Production Specialist

• Oct 2016 - Sep 2017

- Responsible for production and packaging of solid products according to cGMP and local regulations. - Planning, follow up and managing of the production and packaging process. - Assessment monthly activity report and presentation to director of the factory. - Ensuring that performing all production and packaging operations in accordance with cGMP rules. - Ensuring that all personnel administration, planning and realization of the necessary training. - Giving suggestion about improvement and development of production and packaging operations, encourage to give suggestion, assesing suggestion given and ensuring realization. - Identifying targets about efficiency and reducing cost and ensuring implementation. - Ensuring that preparing all procedures and instructions about production and packaging operations and holding actuality. - Ensuring that applying enviromental, occupational health and safety rules in all production and packaging operations. - Supporting internal, external and supplier audit. - Ensuring that supporting R&D activities about new products. - Ensuring that supporting determination of packaging materials belong to new products and giving of necessary approvals. - In order to timely completion of the validation activities, ensuring that performing all neccessary operations in coordination with relevant departments. - Determination of the need for new equipment, ensuring preperation the equipment URS and checking. - Ensuring that identifying and supplying critical parts required of production and packaging equipment. - Ensuring that supporting equipment qualifications. - Ensuring that performing preventive maintenance and equipment calibration by the technical team. Preparing expense, overtime and equipment investment budget and presentation to director of factory.

Formulation Chemist

• Oct 2015 - Sep 2016

Responsible for the projects of pre-development and technology transfer stages of generic drugs. Main development projects are tablet, MDI,OTC and non-sterile liquid products. - Summary of activities: - Manage all aspects of drug product development providing of a full range of technical, regulatory and compliance services throughout Chemistry, Manufacturing and Controls (CMC) drug development, for start-up and from the project inception to approval. - Preparation of development protocols/reports and other technical documentation in support of regulatory submissions. - Preparation and review of CMC sections of all domestic and international regulatory submissions. - Project planning according to current guidances of EMEA and FDA regulations for Orally Inhalation and Nasal Inhalation Products. - Performing Quality by Design (QbD) and Risk Management (FMEA) for pre-formulation design and reports and manufacturing process optimization and validation studies. - Responsibility for all compliance (cGMP) activities, including technical evaluations, internal audits, change control, and training/effectiveness in the research department.