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
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.
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
What we are looking for:
The successful candidate is a quality professional that will thrive in a fast-paced environment where quality is paramount. You will be given the opportunity to own and develop your systems, have a proactive approach in problem solving and identify possibilities for improvement. The successful candidate will have a can-do and patient-centric attitude, strong work ethic and great communication and influencing skills to build fruitful relationships within and outside the business.
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
How to Apply:
Have you ticked the above boxes? Are you ready for a new challenge? If you think you have the qualities we are looking for, then we want to hear from you! Please apply by clicking on the Apply link. A covering letter and resume must be attached.
Further information on our business can be found on our website www.sladehealth.com.au
COVID Health Requirement
In submitting your application, you understand and acknowledge that a state government public health order, direction and/or regulation may be applicable to the workplace and/or role that you are applying for (“COVID Health Requirement”). You acknowledge and agree to comply with any applicable COVID Health Requirement including, but not limited to, providing us with information regarding your COVID vaccination status upon our reasonable request.