Hard working, reliable, motivated and enthusiastic individual with experience in the scientific area
- Coordinating stability trials on early phase clinical material
- Writing, executing, validating and verifying protocols, test methods and reports for new and existing raw materials
- Transferring methods from Parkville to Broadmeadows for the Cell Culture Facility. Following GMP, FDA, TGA and ICH
Writing new protocols and test methods for new and existing raw materials for both Parkville and Broadmeadows sites. Updating and verifying test methods from various departments and sites in accordance with different monographs (USP, EP and BP) and templates from sites and departments. Validation testing using a variety of analytical techniques, i.e. HPLC (H-Class Acquity), AAS and UV Visible Spectrometry.More
- Performing validation, testing on tablets, capsules and intermediates for internal and external customers.
- Contributed to Continuous Improvement projects to improve and promote the 5S culture.
Performing process validation and testing on tablets, capsules and intermediates for internal and external customers in accordance with Good Manufacturing Practice (GMP) and TGA guidelines.More
- Stability testing of new generic oncology drugs before entering the market in accordance with GMP and FDA
- Improved efficiency with stability testing which lead to time saved testing and samples used.
Interval tested new products that are placed on stability under ICH conditions using different analytical techniques, i.e. HPLC, Particle counters, turbidity meters and Karl Fischer. Assisted and conducted studies for different products such as infusion studies, innovator comparison, method validation and investigations.More
- Raw materials and catalyst analysis.Maintenance and calibration of laboratory facilities under NATA and ISO 17025.
- Managed and supervised Lab and liasing with production in regards to sampling.
Batch tested raw materials and finished products and checked that they meet the required standards prior to coating on parts. Checked metal content in catalysts and raw materials using Varian Simultaneous Inductive Coupled Plasma-Optical Emission Spectrometer (ICP-OES) and wet chemistry techniques prior to production. Managed and processed data using LIMS and other programs to approve lots which meet company, ISO/NATA and Siz Sigma Standards.More
- Batch testing of products and packaging. Detecting and reporting any problems with the batches.
- Developing and upgrading new methods for more efficient testing.
Assisting in the introduction, testing and sampling of new products and formulations, including helping set up taste trials. Sending prototypes of new formulations for testing. Answering consumer enquiries and complaints regarding Medical Nutrition products and logging calls in locally and then onto the Novartis global database.More
Education and Qualifications
Achieved a Bachelor of Science from Monash University with majors in Chemistry and Pharmacology Achieved a Certified Associate in Project Management from PMIMore
|2014||Certified Associate in Project Management||Certificate||Project Management Institute||No|
|2007||Bachelor of Science||Bachelor Degree||Monash University||No|
Achievements and Awards
A passionate, experienced professional with a corporate background in heavily regulated pharmaceutical/ complementary health manufacturing environments. Proactive in Continuous Improvement, maintaining consistency, provision of training, safety and compliance, extensive experience in testing, Process Validation, GMP and Quality.
- Word (Advanced)
- Excel (Intermediate)
- Power Point (Intermediate)
- Access (Intermediate)
- Acrobat Pro (Advanced)
- Photoshop Pro (Intermediate)