Senior Process Quality Assurance Engineer Logistics Bioatrium
vor 4 Wochen
Job Summary
Lonza is a global leader in life sciences operating across three continents. Our success is driven by talented people working together to devise innovative solutions that help businesses improve people's lives. As a Senior Process Quality Assurance Engineer in our Logistics team, you will play a key role in optimizing and improving quality processes, compliance, and systems involved in the logistics operations of Lonza.
Key Responsibilities
- Execution of practical project work within a cGMP regulated environment.
- Implicit lead function in process execution can be assigned.
- Take over assigned projects (SAP/MES/Delta V/LIMS) within the BioAtrium area.
- Integrate logistics processes with BioAtrium Quality systems.
- Develop a Quality continuous improvement culture in Logistic Team.
- Structure the documentation and provide support on complex Trackwise and DMS platforms to ensure compliant operations and avoid deviation.
- Author, review, and implementation of process-related procedures (Standard operation procedures, Reports, etc.).
- Identify areas for improvement, optimize operations, and ensure traceability and avoid mix-up throughout the supply chain.
- Reporting of non-conformances and initiation of quality issue records and investigations as well as corrective actions under cGMP.
- Evaluate process performance and deviations while implementing a culture of continuous improvement within the logistics function.
- Develop and implement quality performance measurement systems, conduct regular audits, and drive 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.
- Liaise with internal and external stakeholders such as Manufacturing, Site Distribution/Logistics, and Quality.
- Support and ensure audit readiness.
Requirements
- 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 Quality position and good knowledge of Logistics process.
- Strong experience within a cGMP environment (Change Controls, CAPA's, Deviations, etc.).
- TW knowledge is a must.
- Confident handling of MS-Office.
- Experience with ERP Systems SAP. EWM knowledge will be considered as an advantage.
- Strong problem-solving skill.
- Ability to work according to tight and changing timelines.
- Accurate working and documentation style.
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