Data Integrity Assurance Manager

4 weeks ago

Lucas Heights, Australia ANSTO Full time

**Position Overview**:

- Ongoing | Full Time | $107k - $120k +15.4% super
- Challenging and impactful work that helps ensure GMP Data Integrity compliance across Nuclear Medicine
- Sutherland Shire location I Free parking I Flexible workplace arrangements I Onsite Childcare

**About the Opportunity**:
The primary objectives of the Data Integrity (DI) Assurance Manager are to:

- Establish a framework for GMP Data Integrity compliance across Nuclear Medicine.
- Co-ordinate the activities of the Nuclear Medicine GMP Data Integrity programme ensuring they are executed in accordance with requirements within the current Australian Code of GMP for Medicinal Products:

- During introduction of new processes, systems, and equipment.
- Changes to existing processes, systems, and equipment.
- Continuous review and monitoring of GMP Data Integrity controls within Nuclear Medicine.
- Consult and provide advice to ANSTO on GMP Data Integrity.
- Support the development of GMP Data Integrity-related requirements and specifications for processes, systems, and equipment, ensuring PIC/S GMP Annex 11 and PIC/S Data Integrity Guidelines (PI-041) requirements are met.

**About You**:

- "We are seeking a seeking an experienced and self-motivated professional with an acute understanding _of GMP Data Integrity requirements in a unique environment."_

**Your Duties and Responsibilities**:

- Subject Matter Expertise (SME) for all GMP Data Integrity operational compliance matters impacting Nuclear Medicine.
- Provide updates to ANSTO Business Units on changes to Data Integrity regulatory requirements that impact paper-based processes, computerised and hybrid systems in Nuclear Medicine.
- Coordinate integration of GMP Data Integrity principles into the Pharmaceutical Quality Management System (PQMS) for all processes, systems and equipment supporting GMP processes across Nuclear Medicine.
- Develop, maintain, and enhance the GMP Data Integrity framework (procedures, work instructions, templates, and training material) that impact paper-based processes, computerised and hybrid systems in Nuclear Medicine.
- Ensure data integrity requirements are in place and in use for manufacturing and laboratory technology supporting GMP processes.

**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 Michael Gobrial 0477 316 789. For all other queries please contact Talent Acquisition on (02) 9717 9912.

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

**Application closing date: 11:59pm,Tuesday 15 August 2023.**

**_All applicants must be Australian citizens._

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