Quality Systems Associate – Slade Health
- Dynamic and Supportive Work Environment
- Play a key role in ensuring the compliant operation of a network of TGA Licensed compounding facilities, maintaining the overarching quality systems and supporting both site-based and national teams
- Permanent Full-Time Position
- May be based at Geebung (QLD), Mt Kuring-gai (NSW) or Mount Waverley (VIC), for the right applicant
Slade Health is a national provider of aseptically compounded chemotherapy, antibiotics and analgesic medicines. It operates TGA Licensed manufacturing facilities in Victoria, Queensland and New South Wales.
About the Role:
This role operates within the Regulatory, Medical and Scientific Affairs Department and will focus on the development and maintenance of the Slade Health Quality Management Systems.
You will be welcomed into a close-knit team as a champion of Quality. Our team are dedicated to ensuring that the systems that support our compounding operations are operating to the highest quality standards, so Slade Health will always provide the best possible care for the patients who use our products.
Your work will focus on Quality Systems. You will support all the Slade Health teams – across all our facilities and operations to develop, control and maintain our Document Control systems, evaluate, approve and maintain GMP and regulatory aspects of Supplier and Customer management and co-ordinate and perform the yearly Internal Audit program.
In this role you will maintain, improve and evaluate quality systems to ensure reliability and compliance with company standards and regulatory requirements. You will learn about Slade Health’s Quality Management System infrastructure, earn mastery of MasterControl, and become familiar with how our systems operate to ensure compliance with the TGA’s expectations, the requirements of Good Manufacturing Practice (GMP) as defined in PIC/S, and state health legislated requirements for wholesale supply of scheduled drugs.
In this position you will:
- Function as Document Controller
- Conduct supplier evaluation and monitoring of ongoing supplier performance
- Conduct customer evaluation and maintain customer GMP Agreements
- Co-ordinate and participate in the external (supplier) and internal audit programs
- Conduct and document non-conformance investigations, CAPA, risk assessment, change control activities and document and process review
- Participate and support of external audits, including TGA 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.
Qualifications & Experience
Degree qualified in a related Science Discipline: (Biochemistry, Microbiology, Pharmacy, Chemistry, Biotechnology or equivalent)
Experience, Knowledge, Skills & Abilities
You will also be able to demonstrate the following:
- Two years experience in a TGA licenced manufacturing environment or equivalent
- Sound knowledge of Quality Management Systems, Unplanned Quality Events, CAPA and Change Controls
- Knowledge of Good Manufacturing Practice, PIC/S and the Australian regulatory framework for Scheduled Drugs and Wholesaling.
- Experience in documentation control and technical writing of standard operating procedures and work instructions.
- Strong analytical skills and experience managing data sets is required
- Intermediate to advanced level of MS Excel, Word, PowerPoint and Outlook skills
- 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
- Experience supporting regulatory inspections and supplier audits
- Experience with supplier qualification process (ideal)
This role is offered on a permanent full-time basis working 76 hours per fortnight.
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