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- Developing and maintaining Quality Management Systems, Practices and Plans to ensure the quality of all products meet GMP and TGA requirements
- As the businesses Authorised person, performing release for supply of finished products
- Fostering collaboration between departments to ensure implementation of the QMS
- Reviewing and authorising any change controls, deviation-motivated initiatives and OOS's to ensure completion
- Performing GMP compliance internal audits of the facilities
- Providing GMP training to staff and maintain an ongoing training schedule
- Reviewing and approving all GMP agreements with customers and 3rd party manufacturers
- Managing all IQ/OQ/PQ qualification of equipment in production
- Investigating all customer complaints, initiating or recommending CAPA where required
- Establishing and ensuring a validation plan that includes system, equipment and instrument qualification and calibration
- Evaluating batch records, coordinating and controlling all activities of the QA department leading to the timely release and delivery of quality products according to established priorities and schedules
- Acting as the Product Recall Coordinator (liaising with the TGA, establishing and maintaining recall procedures, examining recall causes)
- Managing the preparation of SOP's and PQR's
QA Manager - Sydney, Australia - Coadys Personnel Consultants
Description
North Shore & Northern Beaches, Sydney NSW
Quality Assurance & Control (Manufacturing, Transport & Logistics)
Our client is a successful and rapidly expanding manufacturing organisation specialising in the medical and healthcare sector. With a large team of around 70 staff, this position will be responsible for heading up the QA function.
Working closely with Management and supervising 4 personnel in this team (including QA Associates), specific responsibilities will include:
This is a dynamic team requiring someone with energy and drive so if this sounds like you and you meet the above criteria, forward your CV to Coadys for immediate consideration
Please note only shortlisted candidates will be contacted.
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