Manage material / supplier qualification in compliance with cGMP requirement and internal procedures.
Manage QA review and release of incoming materials and sterile buffers in compliance with cGMP requirement and internal procedures.
QA review and approve LSOPs, checklists, incoming material documentations, deviations, CAPAs, change controls, and quality tag outs, in accordance with quality and compliance expectations.
...
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.
...
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.
...
Decommissioning of QC equipment and maintaining up to date the lab equipment inventory.
Participate in proper documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
Support laboratory qualification Investigation and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
...