Skills
Product development,analytical, cross functional team work, UPLC, technical documentation, quality control, quality assurance, regulatory submission, research and development, team management, communication, GMP, GLP, regulatory standards, product stability, CMC, laboratory skills, wet chemistry, author and reviewer of documentation, training, audit, troubleshooting, project management, characterisation, root cause analysis, project planning, organisation, data analysis, scientific investigations, data compilation.
About
I hold a pharmaceutical biotechnology undergraduate degree and post graduate diploma in Bio Pharmaceutical processing. I have over four years of pharmaceutical industry experience with
expertise in drug product development, validation, technical documentation, team management,
and cross functional teamwork. In my previous promotive role as an Analytical researcher at Teva pharmaceuticals I co-ordinated analysts development and stability testing for finished drug
product, supporting validation and tech transfer activities. I have extensive experience in the preparation of Module 3 submission documentation by authoring and reviewing test protocols, methods and reports. I have led and supported complex analytical
investigations in trackwise, providing route cause analysis and risk-based solutions to ensure process robustness and timely delivery of project objectives. I supported continuous improvement of the analytical research and development department by contributing to initiatives such as the 6S
team. I have strong cross functional collaboration expertise from providing technical support in CMC meetings across several departments and senior leadership teams to resolve manufacturing and analytical challenges.
I assumed full managerial responsibility during leadership absence ensuring all work was completed to cGMP, GDP, GLP and regulatory standard. From my experience as a research and development analyst I have technical expertise in finished product analysis, method development, validation, and testing. I was responsible for developing and executing training regimes and all associated documentation for new analysts.
I have recently relocated to Melbourne and hold a valid three-year work visa with full Australian working rights through my partners sponsorship with EY Melbourne. I look forward to the opportunity to discuss how my background, skills and enthusiasm align with any potential opportunities.
Please feel free to contact me on my mobile 0449946792 or email ([email protected])
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