Quality Systems

2 weeks ago

Lucas Heights, Australia ANSTO Full time

**Position Overview**:

- Ongoing| Full Time | $129- $144k +15.4% super
- Work-life balance | Free onsite Parking | Health & Wellbeing Programs | Sporting Facilities
- On-site Childcare for employees | Work in a campus-based community environment | Cafe on site
- Looking for someone with experience with management of quality systems & end-to-end GMP manufacturing experience?

**About the Opportunity**:
The Quality Systems & Compliance Manager manages the quality system functions of Nuclear Medicine to ensure compliance with the requirements of the TGA licence to manufacture therapeutic goods, Nuclear Medicine Product Quality System (PQS) and other regulatory requirements. This includes:

- Developing and maintaining the licensed state to manufacture both finished goods and APIs through oversight of the Pharmaceutical Quality System (PQS) with established standards and agency guidelines to ensure compliance.
- Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards, and business needs.
- Manage quality systems inclusive of management of change (MOC), corrective actions and preventative actions (CAPA), audits, document management, deviations, supplier management, out of specification-tolerance(OOS-OOT), Product Quality Review (PQR), customer complaints, and sterility assurance.
- Management of validation schedule ensuring compliance for process, equipment, and computer systems
- Management of Sterility assurance ensuring regulatory compliance

**About You**:
**Your Duties and Responsibilities**:

- Managing all quality systems for Nuclear Medicine
- Monitor and report on all quality metrics and trends
- Manage qualification and validations to ensure all compliance expectations are met
- Subject matter expert for sterility assurance and determine continuous improvement initiatives
- Lead education programs for compliance requirements across relevant facilities
- Oversee transition to revised PIC/s Code to GMP Annex 1

**About Us**:
**Benefits of Working with Us**:
ANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians.

We support and reward our employees through eligibility for:

- Training, development and mentoring opportunities
- Performance based salary increases
- Work-life balance with generous leave entitlements and flexible conditions

**How to Apply**:
For further technical information relating to this position please refer to the Position Description or contact Lee-Ann Carrasco on (+61) 476 246 149. For all other queries please contact Talent Acquisition on +61 (02) 9717 9361.

To be eligible for appointment, applicants will require a security and pre-employment medical assessment.

**Application closing date: 04 November 2024 at 11:59pm**

**_Australian citizens preferred_

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