Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
Drive, support and champion KPIs, key Quality metrics, etc.
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-Plan and manage various phases of EOD runs (SIT, UAT & Regression)-Murex Performance & Automation Lead-Liaise with teams on batch job setup requirements and also work with Business units on authorized ad-hoc requests-Investigate the Job failure and take appropriate action.
- 10+ years o total working experience including at least 7 years of experience with Murex
Keeps up-to-date on regulations/ development of biopharmaceutical QC method/ technology to ensure the project maximizes the use of digitalization, automation and robotics.
Works closely with global/local QC stakeholders to develop and endorse the following: Analytical transfer plan, validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global and Belgium QC departments on test method innovation/ evaluation to support the project team in facility design / modification specifically for QC operations.
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Providing troubleshooting support to the operations department
Ensure process optimization for a specific product to make improvements to processes with respect to yield, quality, output, cost savings, robustness etc. in line with Good Manufacturing Practices (GMP) requirements and ensure suitability for Secondary process performance
Undertake troubleshooting of problems relating to the plant/ processes to ensure the effective and prompt resolution of issues/ salvage of batch/ development of novel re-work methods for treatment of substandard batches
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Document and review all FA processes under his or her responsibility in terms of FA machine operating instruction and process work instruction
Venture into new approaches/concepts in product failure analysis techniques and equipment to get the pertinent failure information with less effort and/or time
Maintain an up-to-date knowledge of technology/state of art in the field of failure analysis
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• Testing and debugging of equipment or module prototypes.
• Perform project management, including planning, defining problems and objectives, developing an approach, and providing recommendations.
• Participate in design reviews and prepare design documentations at every stage of development until the final prototype test and characterization.
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