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- Fantasic opportunity with a family owned Australian organisation
- Excellent career potential
About Our Client
Our client is an Australian family owned and operated company based in East Melbourne and have been operating for 17 years. They are one of Melbourne's growing manufacturing businesses producing some of the latest and innovative medical products on today's market. Supplying to dealers and distributors around Australia and across AsiaPac, they specialise in the production of specialist liquids, gels and pastes to the dental and broader health care market.
An opportunity has arisen for an experienced Quality Manager to join their dynamic production environment. The business is currently undergoing some growth and changes both here and in the overseas facility, and as a result has an immediate need for a new member to manage the Quality team. Reporting directly to the General Manager, the QA manager will be responsible for managing all the activities across the Quality department and liaising with the factory floor, operators and the operations team. Duties will include and not be limited to:
- Maintain the Quality management System and corporate compliance to ISO 13485 and ISO9001
- Ensure conformance of product within the group of companies an hold responsibility for product quality and release of sale functions
- Maintain an audit ready status across the the group and manage all regulatory audits
- Preparation and maintenance of all documentation related to product Quality and conformance
- Update of company training programs and records
- Ensure all staff, contractors and consultants meet their requirements and comply with all required quality standards
- Manage and maintain company systems "Change Control", NCR and "Customer Complaint" systems
- Ensure compliance with OH&S requirements and report on company risk management systems
Other duties such as Post Market review, Supplier Management, Regulatory Support, Agency Interaction (FDA and TGA)
The Successful Applicant
The successful applicant should possess the following skills.
- Ideally possess a relevant Science/pharmaceutical/Chemistry background.
- An extensive background working in the Pharmaceutical Quality space. Minimum 5 years
- Must have a vast knowledge of HACCP, GMP and experience with leading audits
- Sound leadership and good communication skills.
- Dealing with customer complaints and experience with management of suppliers
- Good knowledge of regulatory affairs
What's on Offer
An attractive salary package will be on offer to the successful candidate along with the opportunity to take leadership and mould the Quality department and take to the next level of operational excellence.