Quality Manager

1 week ago

Sydney, Australia Icon Group Full time

**Quality and Safety**

**Sydney**

**Full Time**

**Slade Health**

**Quality Manager - Slade Health Laboratory**
- Be part of Slade Health’s established Quality Assurance team, working in a dynamic and supportive work environment
- Maintain Quality oversight of Scientific department and Laboratory activities to ensure GMP compliance and high standards of quality are maintained, including for:

- Physicochemical and biological stability studies of compounded medicines
- Testing of environmental samples from the manufacturing environment
- Permanent Full-Time Position - Mt Kuring-gai, NSW Location

**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 and New Zealand. Our Laboratory undertakes stability studies to support the extension of product shelf-life, enabling patients to be treated with cutting-edge medicines closer to home.

**Key Responsibilities**
In this role you will have responsibility for the Laboratory’s GMP Licence and other Accreditations, Permits and Licenses. You will work closely with the Principal Scientist to ensure Slade Health’s Scientific activities and the Laboratory comply with regulatory expectations and Slade Health’s Pharmaceutical Quality System. You will be involved in and have Quality oversight of Scientific studies and testing activities.

**What We are Looking For**
You will be able to demonstrate the following:

- A good knowledge of Good Manufacturing Practice and PIC/S
- Experience driving Quality in a GMP licenced environment or equivalent.
- Strong knowledge of Pharmaceutical Quality Systems, including:

- Document Control and Training
- Non-Conformance, Deviations and Complaints
- Risk Management, CAPA and Change Control
- Validation and Supplier Management
- Continuous Improvement and Audit Programs
- Strong analytical skills and experience managing data sets.
- Knowledge of:

- Biological molecules such as monoclonal antibodies and antibody-drug conjugates
- Methodologies such as HPLC, CE, ELISA, protein-binding assays, etc.
- Stability study design principles
- Previous laboratory experience is desirable.
- Advanced skills in MS Excel, intermediate skills in the general MS Office suite
- Ability to communicate effectively with peers, management, suppliers and 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:

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