Idustrial & Logistics Specialist
We are looking for an Industrial and Logistics Specialist for an exciting Medical Devices company based in Milan.
Responsibilities
Process and Equipment:
- Manage the design of a GMP compliant facility and related equipment and provides technical recommendations to permit plant operation within regulatory requirements.
- Cooperate with manufacturing, maintenance and quality teams to support the continuous improvement in the production areas by improving OEE, optimizing layout and reducing waste.
- Conduct detailed time studies, develop process flow diagrams and work measurements to analyze existing work processes and identify areas for improvement
- Recommend and complete modifications to equipment to enhance productivity and efficiency.
- Coordinate activities to address equipment performance issues.
- Develop regular routine planned maintenance tasks for the production line equipment in line with the procedures.
- Follow best practices around Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) with a goal to develop Safe and Quality Processes.
- Apply the Company’s Quality Management System in all activities performed.
- Stay updated on Health and Safety legislation and ensure compliance.
- Participates in preparing the company for inspections by Competent Authorities and contribute to their successful outcome by collaborating on the implementation of any corrective actions.
- Identifies actions to ensure continuous updates and role adequacy in relation to new required knowledge.
Logistics
- Manages the company’s Warehouse, including: managing goods (tools, equipment, raw materials,
consumables) entering or leaving the warehouse, recording the movements of the goods, checking the delivery notes, DDT, codes and transport documents of the products, ensuring the integrity and correct storage of the goods in the warehouse, in compliance with internal procedures and company safety regulations. - Collaborates on the monitoring of the environmental conditions in the company’s premises, ensuring that the optimal conditions for production activities are maintained.
- Collaborates in the development of the engineering documentation necessary for the definition of technical and functional specifications of existing and new equipment
- Ensure compliance with safety regulations and company policies.
- Supports the creation of training documentation and delivers training where appropriate.
- Collaborates with other functions of the site and external contractors to perform the equipment validation activities, in compliance with the internal guidelines.
- Ensures that the validation documents issued by supplier and contractors, related to infrastructure and logistics activities, are compliant to the company’s internal standards.
- Collaborates with the teams on investigation, resolution and prevention of product and process non-conformities.
- Participates in the drafting of production QMS documents, such as: standard operating procedures (SOP) and work instructions (WI), non-conformities, change requests.Maintain and update quality documentation and records in accordance with company policies and regulatory requirements.
Requirements
- MSc in Scientific disciplines, Engineering or equivalent qualification;
- Experience with Risk Analysis methods (e.g. FMEA)
- Precision, reliability, and the ability to work independently.
- At least 2 years of experience in the manufacturing environment.
- Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities.
- Knowledge of quantitative and qualitative approaches, as well as the organisational, operational, and technical aspects of businesses.
Interested? Apply today to become a key contributor to our client's team!