Validation Associate - Technical Writer
Opportunity to support one of Australia's largest public research organisations, delivering innovative scientific service and providing specialised advice to government and industry.
In this key role to the organisation, you will be responsible for technical writing of validation documentation including retrospective validation and revalidation of processes, in addition to conducting and reporting on validation testing.
Some of your key responsibilities will include:
- Ensure good manufacturing practices (GMP) are adhered to across the organisation.
- Writing organisational Validation activities in accordance with GMP requirements, for process, cleaning, and computerised system validations.
- Ensure current industry thinking on validation principles is applied.
- Perform installation and operational qualification (IQ/OQ) relating to procedures, equipment and processes.
- Tracking the preparation and approval of qualification and validation protocols
Knowledge, Skills and Experience Required:
- Relevant degree qualifications in science or engineering
- Knowledge of pharmaceutical manufacturing and quality systems
- Understanding and experience of regulatory body requirements (eg TGA, FDA)
- Highly developed technical report writing skills
- Microsoft Office & SAP
- Validation experience in the pharmaceutical / radio-pharmaceutical industry would be highly regarded
Must be an Australian Citizen to apply
To secure this opportunity, you must demonstrate previous experience and relevant degree qualification or equivalent and well developed communication skills.
This is a great opportunity to work within this quality company
APPLY NOW or call Jacob / Charlotte on (02) 9317 2333