Validation Associate /Technical writer
2 year full time contract role
About Our Client
My client is a national organisation for science and technology focusing on leading edge research, innovation, providing advice to the government, industry and R&D organisations. The organisation's manufacturing facility follows GMP code while making sure its processes meet certain standards where time is critical using the Just in Time principle. The client holds a dominant market share position in Australia and worldwide.
- Ensure GMP standards are followed
- Ensure current industry thinking on validation principles
- Writing validation activities in accordance with GMP for process, cleaning and computerised system validations which could include plans, reports for URS, DQ's,IQ,PQ using a risk based approach
- Tracking and approval of validation protocols
- Providing validation advice and input on new projects ( manufacturing systems, equipment, computer systems, equipment, computer systems, new products)
- Act at quality approve for validation activities when required as per GMP code of conduct
- Train production personnel as required for newly validated processes and equipment.
- Ensure actions from validation activities are captured in the site Corrective and Preventative Action system
- Co-ordinate impact assessments relating to validation and qualification.
- Undertake additional duties as required and during periods of leave of other staff.
The Successful Applicant
- Highly developed technical report writing skills
- Relevant degree qualifications in science or engineering
- Knowledge of pharmaceutical manufacturing and quality systems especially validation
- Experience with Microsoft Office & SAP
- Demonstrated leadership, communication and project management skills
- Target oriented
- Understanding and experience of regulatory body requirements (eg TGA, FDA)
- Validation experience is preferable in the pharmaceutical / radio-pharmaceutical industry
What's on Offer
Working with this National organisation you will be rewarded with a lucrative remuneration package. Operating within a dynamic and fast-paced environment, you will enjoy functioning within a role which offers the opportunity to broaden your skill set and develop your capabilities with a real opportunity to influence the process with the company.