We are seeking a suitably experienced Validation Associate to join our Quality team. The Validation Associate is responsible for ensuring the timely completion of assigned validation activities and routine calibration schedules.
Tasks will include, but are not limited to:
- Undertake validation activities as directed to support Equipment Validation, Cleaning Validation & Computer System Validation.
- Review and update existing procedures or create new procedures identified during validation activities.
- Review legacy manufacturing processes for adherence to dossier.
- Conduct validation activities based upon outcomes.
- Assist when required with the introduction of new product to the facility or remediate product deficiencies as identified.
- Ensure documentation is compliant to APVMA/TGA/FDA licensing conditions (product dependant).
- Maintain and develop the Calibration status of existing and new equipment.
- Co-ordinate external calibration contractors onto the Jurox site, limiting disruption to production and R&D activities.
- Internal calibration of existing equipment.
- Assist and attend as requested all internal and external GMP related facility audits.
- Provide assistance to the Quality Control Manager relating to the execution of the Validation Master Plan.
- Contribute to a continuous improvement culture and partnership within the Engineering, Validation and Production teams that will provide value adding results to the business
- To ensure all equipment is maintained in a GMP compliant state.
- Minimum of 3 – 5 years in a TGA or APVMA licensed manufacturing facility (desirable)
- 3 – 5 years exposure to validation and calibration programs within a complex and regulated manufacturing environment (preferably pharmaceutical)
- Strong health and safety awareness
- Excellent communication, sound skills in working to deadlines and strong ability to prioritise tasks
- Strong computer skills including proficient use of Microsoft
- Ability to work independently, as part of a team and cross-functionally
- Ability to develop and maintain collaborative relationships departmentally and inter-departmentally with collegiality
- A positive and responsible attitude, strong work ethic and the ability to learn tasks quickly
If your experience, skills and educational qualifications fit this profile, please submit your application.
RECRUITMENT AGENCIES NEED NOT APPLY
Only those with the existing right to work in Australia will be considered