QA Manager

4 days ago

Mona Vale, New South Wales, Australia Coadys Personnel Consultants PL Full time $120,000 - $180,000 per year

Our client is a successful and rapidly expanding manufacturing organisation specialising in the medical and healthcare sector.  With a large team of 100+ staff, this position will be responsible for heading up the QA function.

Working closely with Management and supervising 4 personnel in this team, specific responsibilities will include:

  • 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

To be considered for this position you will be a passionate and knowledgeable QA professional with a minimum of 5 years experience ideally in the medical / pharmaceutical sectors and have strong GMP and TGA knowledge, including compliance audits.  You will be an experienced team leader who is capable of giving clear direction yet happy to be hands-on where required.  Ideally you will be tertiary qualified and live within a reasonable driving distance to the Northern Beaches (due to location, a car would be required and parking is provided).

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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