Quality Systems Associate

**Quality and Safety**

**Sydney**

**Full Time**

**Slade Health**

**Quality Systems Associate - Slade Health**
- Be Part of An Exciting Team working in a Dynamic and Supportive Work Environment
- Play a key role in ensuring the compliant operation of a network of GMP Licensed compounding facilities, maintaining the overarching quality systems and supporting both site-based and national teams
- Permanent Full-Time Position
- Preferably based at Mt Kuring-gai (NSW), but for the right applicant the role may be based at any Slade Health site
- Flexible Work Arrangements possible - part time working from home

**About Slade**:
Slade Health is a leading provider of aseptically compounded chemotherapy, antibiotics, parenteral nutrition and analgesic medicines. We operate GMP Licensed manufacturing facilities in Australia (Mount Waverley VIC, Geebung QLD, Mt Kuring-gai NSW) and New Zealand (Auckland)

**About the Role**:
As Quality Systems Associate you will be integral to the development and maintenance of Slade Health's Quality Systems. You will support Slade Health teams - across all our facilities and operations (compounding, laboratory, warehousing) to develop, control and maintain our Document Control systems, evaluate, approve and maintain GMP and regulatory aspects of Supplier and Customer management and drive the Internal Audit program. You will support day-to-day operations as well as be involved in special projects across multiple regulatory regions.

Key to the role is compliance to PIC/S PE009 Good Manufacturing Practice and AU/NZ Good Wholesaling Practices, and the ability to develop, implement, improve and maintain compliant systems and processes. You will have independence to drive key systems, while working within a close-knit and supportive team.

Our Quality Systems team engage with and support the entire business, to enable A1 ratings at regulatory inspections and ensure only the highest quality medicines are supplied to hospital patients throughout Australia and New Zealand.

**Key Responsibilities**:
In this position you will:

- Function as Document Controller
- Conduct supplier evaluations, monitor ongoing supplier performance and maintain Quality Agreements
- Conduct customer evaluations and maintain GMP Agreements
- Conduct external (supplier) and internal audits (auditing each business area and general quality of GMP records)
- Conduct and document non-conformance investigations, CAPA, risk assessment, document review and change control activities
- Participate in and support regulatory audits
- Reporting on QMS performance and KPIs

You will contribute to ongoing continuous improvement in Quality performance across the business. This means implementing improvements to raise compliance and efficiency and engaging with stakeholders to promote the Quality culture.

**What we are looking for**:
**Experience, Knowledge, Skills & Abilities**
You will be able to demonstrate the following:

- Experience driving Quality in a GMP licenced manufacturing environment or equivalent
- Strong knowledge of Quality Management Systems and the compliant management of Quality Events, CAPA and Change Control
- Experience in Good Manufacturing Practice, PIC/S and the Regulatory frameworks for Scheduled drugs and wholesaling of medicines
- Strong analytical skills and experience managing data sets
- Advanced skills in MS Excel, intermediate skills in the general MS Office suite
- Ability to communicate effectively with peers, management and externally with customers, suppliers and when required regulatory bodies.
- Strong task and time management skills. You will work in a fast-paced environment, and you will need to be able to effectively co-ordinate, track and prioritise tasks to deliver to tight timeframes

This role is offered on a permanent full-time basis working 76 hours per fortnight.

**How to Apply**:
COVID Health Requirement