Aus quality Associate

2 weeks ago

Moorabbin, Australia PCI Pharma Services Full time

It's fun to work in a company where people truly BELIEVE in what they are doing

We're committed to bringing passion and customer focus to the business.

Purpose: The purpose of the Quality Control (QC) Associate-Incoming Receipt and Release is to support the QC Team Leader in ensuring PCI procedures are adhered to for the receipt, testing and management of incoming materials at PCI. All aspects of this role are performed in accordance with the Therapeutic Goods Administration Release for Supply of Medicines and technical Guidance on the interpretation of the PIC/S Guide to GMP.

General: The role requires quality oversight and preparation of some quality control documents. These include, but are not limited to: - specifications - review of test results review (e.g supplier CoA) - quality approval of operational records (e.g goods receipt documents), - some physical movement and counting of pharmaceutical products and raw materials.

The primary responsibilities of this position are:

- The receipt, testing, review, inspection, quarantine and disposition (release or rejection) of incoming materials for use in production, in accordance with company procedures.
- Ensure to have current knowledge of the suppliers, the supply chain and the associated risks involved for the products purchased or received
- Periodic checking of status of starting materials, packaging materials and incoming goods until they have been released for production use or distribution
- Preparation of SOPs and maintenance of management tools such as Excel spreadsheets.
- Support the close out of Deviations, CAPA, change control, non-conforming materials/products
- Assist with maintenance of the Material code list, Approved supplier list.
- Facilitate required information /metrics for the QSRT including tracking of SOPs approaching review date.
- Other duties as directed by the QC Team Leader.

The position will report to the QC Team Leader and will ensure that all materials / products received and released for use comply to all requirements and are receipted and released in a timely manner to meet Production schedules.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us

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