Product and Raw Materials Testing:
- Develop and qualify method of analysis (MOA) for QC lot release testing
- Perform analytical testing such as flow cytometry (FACS) and qPCR assay to support QC lot release.
- Perform stability testing of released final products as per protocol and timeline.
- Perform functional/comparability testing of raw materials such as plasmid, media, reagents and etc.
- Support assessment of certification/accreditation and services provided by external labs for QC lot release testing
Documents and Data Management
- Drafting and updating of relevant SOPs and specification documents for lab, equipment, test method, training and raw materials.
- Author and review technical protocols and test reports, develop guidelines and standard practices for data documentation and analysis.
- Review test results, document data and produce trends in an efficient, organised and presentable manner to facilitate discussions, and to support business and performance metrics reporting.
Deviations and Audit Management
- Assist OOS/test deviations initiation, investigations, root cause analysis and CAPA implementation for product defects and quality lapses.
- Support internal and external audits/inspections.
Equipment and Lab Management
- Monitor and schedule equipment calibration and maintenance as per schedule and site master file.
- Perform lab housekeeping, equipment, inventory, lab cleaning and biohazard/waste management.
- Perform monitoring and procurement of lab inventory, for e.g. materials and cosumables.
Continuous Improvement
- Implement initiatives to encourage improvement of QC procedures, activities and workflows.
- Conduct routine literature review through established publication channels to ensure continual knowledge proficiency on both GMP and current technological trends relevant to CellVec activities.
