Experience

Aspen Pharma Australia

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Validation Technologist

  • Apr 2008 - Present

  Follow Master Validation Plan to plan and control all validations on site.Generate all relative documentation (protocols and report on a web-based system) and perform executions (executions include: concurrent validation or process optimisation (CAPA) of existing products, technical transfer and introducing of new products, for Process on site according to Master Validation Procedure.Manage a Cleaning Validation Matrix according to Master Cleaning Validation Plan.Generate all relative documentation for cleaning validation (Protocols and Reports) according to Master Procedure.Perform all evaluations on new Facilities and CIP's.Support to all relative departments for in depth investigations for both Cleaning and Process validation related issues. Show less

• Validation Analyst

  • Jan 2007 - Apr 2008

  •Testing of Process validation samples for the Technical support department using all Laboratory equipment and specifications•Ensuring all results are accurate and precise as statistical evaluation of the process is critical for Validation purposes•Following all specific SOP’s as required•Writing and updating SOP’s for the department•When finished with the tasks allocated, then following up with supervisor for additional work.•Performing method validations according to the departments schedule•Following up with supervisor to ensure correct data is presented•Recommend method improvements as they are identified as potential cost or time saving improvements •Submitting specification changes as a result of the work performed above•Following all departmental Safety and GMP requirements at all times Show less