Senior Process Quality Assurance Engineer
Vor 6 Tagen
We are seeking a highly skilled Senior Process Quality Assurance Engineer to join our team at Lonza. As a key member of our logistics operations, you will be responsible for optimizing and improving Quality processes, compliance, and systems involved in the movement and management of goods and materials throughout the supply chain.
Key Responsibilities- Execute practical project work within a cGMP regulated environment, with an implicit lead function in process execution.
- Take over assigned projects (SAP/MES/Delta V/LIMS) within the BioAtrium area, integrating logistics processes with BioAtrium Quality systems and developing a Quality continuous improvement culture in the Logistic Team.
- Author, review, and implement process-related procedures, identifying areas for improvement, optimizing operations, and ensuring traceability to avoid mix-up throughout the supply chain.
- Report non-conformances and initiate quality issue records and investigations, as well as corrective actions under cGMP.
- Evaluate process performance and deviations, implementing a culture of continuous improvement within the logistics function by developing and implementing quality performance measurement systems, conducting regular audits, and driving right-first-time methodologies.
- Propose new or improved technologies to enhance quality efficiencies and regulatory compliance.
- Collect and analyze data on key logistics quality metrics to identify trends, patterns, and areas for improvement, using statistical analysis tools and software.
- Liaise with internal and external stakeholders, including Manufacturing, Site Distribution/Logistics, and Quality.
- Support and ensure audit readiness.
- A minimum of a Bachelor's/graduate degree in Logistics Management, Supply Chain, or equivalent.
- Higher technical education qualification with several years of experience in a Quality position and good knowledge of Logistic processes.
- Strong experience within a cGMP environment (Change Controls, CAPA's, Deviations, etc.), with TW knowledge a must.
- Confident handling of MS-Office and experience with ERP Systems SAP, with EWM knowledge considered an advantage.
- Strong problem-solving skills.
- Ability to work according to tight and changing timelines.
- Accurate working and documentation style.
At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. We offer a dynamic career path, with potential and exciting possibilities for growth and professional development.
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