Quality Assurance Manager - ref. i34623503
Quality Assurance Manager
For Contract Manufacturing & Packaging Services Pty Ltdbased 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.
The successful candidate will be responsible for administering a robust internal quality control system in our reputed organisation in the pharmaceutical industry.
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)
An additional Master degree in Biotechnology or Biochemistry will be desirable.
The salary for this position is $115,000.00 plus superannuation.
The candidate should be self-motivated, be able to work well under pressure, and a team-player with excellent communication skills, both written and verbal. Attention to detail is important in the role. We are looking for someone with a positive attitude and is a self-starter.The candidate must be hard working, organised, creative and passionate about working in a team environment. He or she will be required to work in a high-pressure environment.
We have a good team environment based in Smithfield. Please send your resume to CMPS, 20-22 Long Street, Smithfield, NSW 2164, Australia or info@cmpsaustralia.com.
Application closing date 30 March 2024.