Assist in QC instrument and equipment management, such as C-type instruments including HPLC, GC, IC, and LC-MS, as well as B-type instruments like pH meters, balances, and color meters.
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Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility
Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience
Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections
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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 and Validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global QC networks on test method innovation/ evaluation to support the project team in facility design / modification, specifically for QC operations.
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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 and Validation master plan, cost management (eg. facility, analytical equipment) and training plan
Collaborates closely with global QC networks on test method innovation/ evaluation to support the project team in facility design / modification, specifically for QC operations.
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Determine and implement optimal approach for laboratory equipment calibration, maintenance and operation. Ensure laboratory infrastructure and equipment function as intended.
Perform equipment troubleshooting. Investigate underlying causes, technical faults and issues pertaining to laboratory equipment, method or practices, and take necessary actions to resolve the problems. Communicate and collaborate effectively with vendors and/or internal stakeholders to resolve issues.
Lead, manage and execute projects of small to medium scale and complexity.
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