Quality Assurance Manager

2 weeks ago

Sydney, New South Wales, Australia Cmps Full time

**Quality Assurance Manager**

For Contract Manufacturing & Packaging Services Pty Ltd

based in Smithfield, NSW 2164

Contract Manufacturing & Packaging Services Pty Ltd (hereafter referred to as "CMPS") is a rapidly growing pharmaceutical manufacturing company which has a vacancy for a highly competent and experienced Quality Assurance Manager.

A full-time position for a Quality Assurance Manager is available for an immediate start.

Specific duties and responsibilities for the position of Quality Assurance Manager are as follows:

- Handling TGA, HACCP, HALAL and other Audits from regulatory bodies and clients' audits
- Ensuring that Contract Manufacturing & Packaging Services (CMPS) always remains compliant with TGA requirements
- Preparing and disseminating SOPs relating to quality assurance
- Scheduling and carrying out training of all personnel in cGMP, and relevant SOPs and quality systems
- Leading and training the QA, QC and Regulatory Teams
- Carrying out Supplier/Vendor Qualification for all starting materials (including Raw materials and Packaging materials)
- Handling Supplier Corrective Action Reports (SCARs)
- Managing Change control
- Managing Deviations
- Carrying out Product Validation (Process Validation, Test-Method Validation, etc);
- Making Stability Testing Protocols and ensuring products are tested as per the protocols
- Developing protocol for IQ/OQ/PQ and carrying out IQ/OQ/PQ for production & packaging machinery
- Scheduling and carrying out Environmental Monitoring
- Ensuring that analytical testing is carried out as per relevant monographs (including Chemical and Physical Testing of Raw material, In-process and Finished products);
- Reconciliation of Batch documents
- Releasing Finished products for Sale/Supply
- Carrying out Risk Management; and
- Carrying out PQRs (Product Quality Reviews)

The salary for this position is $115,000.00 plus superannuation.

Application closing date 30 March 2025.

Work Location: In person

Application Deadline: 30/03/2025

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