Senior Officer, Quality Assurance
Incepta BioScience (US FDA Project of Incepta Pharmaceuticals LTD.)
Total des années d'expérience :8 years, 0 Mois
Lead Quality Operation team and prepare workplan per production activity.
Work on US-FDA audit management and facility readiness.
Batch Documents Review, Batch Compilation and Batch Release
Core team member of Equipment Qualification (IQ, OQ and PQ).
Stability Chamber Management, Report and Sample Management
Operate SAP S/4 HANA System to Create PR, Generate GRN, Receive and Release Materials and products
Prepare required SOP and Conduct Training
Review Cross Functional Departmental SOP, Protocol and Summary Report
Reserve Sample Management and Documents management
Perform Sampling of Raw Materials, Packaging Materials, Intermediate, Bulk and Finished Products
Perform IPC Verification, AQL and Batch Note Assessment
Perform Cleaning Verification Sampling and Assist in Validation Study
Supervise Hold Time Study, Photostability Study and In-use Stability Study
Core team member of deviation investigation team
Core team member of audit team
Ensure to Implementation of 5S in the GMP facility.
Batch Documents Review, Batch Compilation and Batch Release.
Perform Annual Product Quality Review (APQR).
Reserve Sample Management.
Documents Issuance, Control and Archival.
Perform Sampling of Intermediate, Bulk and Finished Products.
Perform Line Clearance and In-process check.
Area monitoring regarding GMP Compliance.
Perform Line Clearance and In-process check.
Perform Sampling of Intermediate, Bulk and Finished Products.
Batch Documents Review, Batch Compilation and Batch Release.
Perform Shop Floor monitoring and QA Surveillance Activities.