Experience

Child and Adolescent Health Service

• Australia
• Hospitals and Health Care
• 300 - 400 Employee

• Quality Control Chemist

  • Jan 2018 - Present

  Pharmaceutical Raw Material, Finished Product and Stability testing using reverse-phase HPLC, UV-Vis, Autotitrator, Karl Fischer, Flame Photometer, Polarimeter, pH, Conductivity, Melting Point and Refractive Index instruments, along with Wet Chemistry techniques, according to established methods and specifications in a TGA-approved laboratory. Routine calibrations and general maintenance of all instruments, including 3 x HPLCs (2 x Waters Alliance units with 2489 detectors and 1 x Waters 717 with a Waters 996 PDA detector and Waters 486 UV detector). Additionally, across two facility moves have been responsible for the strip down and setting up of HPLC instruments, including network connections. Validation projects: - Empower 3 software full IQ/OQ (on initial install and updates), database / custom field / methods setup and validation. - PQ of Empower 3 software when operating with a new HPLC system. - Validation of new HPLC Refractive Index detector. - Various temperature mapping (oven, warehouses). - Various raw material and finished product method verifications and validations (either according to BP methods or in-house developed methods where a suitable BP method wasn’t available). - Full IQ / OQ / PQ of Autotitrator and Karl Fischer instruments, plus training of staff on these. Familiar with GMP documents – Involved in writing multiple Deviations, Change Controls, CAPAs, SOPs, URSs, Risk Assessments, Stability and Validation Protocols / Reports, Periodic Evaluations etc. Show less



Perrigo AU

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Control Chemist

  • Apr 2011 - Jan 2018

  Pharmaceutical Raw Material, Finished Product and Stability testing using reverse-phase HPLC, GC, UV-VIS, IR, Kjeldahl Apparatus, Wet Chemistry, pH, Autotitrator, and Karl Fischer Apparatus according to established methods and specifications in a TGA-approved laboratory. Experience in Perkin-Elmer GC with TotalChrom software and Waters HPLC with Empower Software. Was the lead on a project to transfer the GC to Empower software, performing all duties from initial discussions with Perkin-Elmer and Waters, to validation of the software, to set up of all instrument methods, to training of all users (Quality Control and Technical Operations (R&D) staff). Seconded to Technical Operations (R&D) department for one year. In this time worked on primary stability testing / report writing, as well as HPLC method development and validation. Show less