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Assures the maintenance of process analytical tools (PAT) methods and performance in the manufacturing assets in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the area of PAT and contributes with technical expertise to optimize PAT applications.
- Provide technical support (process analytical and statistical) in commercial projects;
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Develop and implement asset management strategies for critical equipment, including PMP, critical spare part identification, and optimization of spare part inventories. Ensure up-to-date and accurate equipment BOM;
- Lead troubleshooting efforts for equipment malfunctions; perform Root Cause Analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA) to minimize downtime;
- Integrate and...
- Develop detailed civil engineering designs and plans for pharmaceutical facilities;
- Conduct site assessments and feasibility studies for new construction projects;
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Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals regularly.
- Lead cross-functional teams to deliver substantial...
