Perform Release for Supply of medicinal products.Conduct routine external/internal GMP audits. Assist with Product Protection Strategies. Assist with Quality System management to ensure products and procedure meet ISO 9001 and GMP/TGA requirements. Coordination and facilitation of core GMP training modules.Participate in the preparation for TGA and Corporate audits.Perform Periodic Product Quality Reviews and data trending to ensure the product met the required process capability (Cp/Cpk).Perform non-conformance investigation, product complaint, CAPA, compounding validation, process validation and continuous improvement.Assist quality risk assessments and communicate with cross-functional teams to resolve quality issues.Investigate processes that deviate from established standards.Coordinate change control and provide change control support by documenting changes, reducing chances of unauthorized activities.Assist in reviewing and revising SOPs to ensure compliance with regulatory submissions and requirements.Coordinate calibration schedule for Lab instruments.

Coordinate Knapp study for Rommelag BFS filling machine.Conduct training for Visual Inspection techniques.Review Batch documents to reconcile Visual Inspection data in LIMS.Collecting of data and writing Annual Trend Report for Rommelag BFS Visual Inspection.Rationale and Risk Assessment of Process Defects during manufacture.Collecting and analysing of data for the investigation of Doxorubicin discoloured solution issue.

Perform QC testing of Raw materials and Finished Product using wet chemical, HPLC/UPLC, GC, UV-Vis and FTIR. Maintain and calibrating of Lab Instruments. Product development and Pilot batches, HPLC method validation and Cleaning Validation.