Job Description

Manage Quality Management System (QMS) activities including customer complaints, deviations, CAPAs, non-conformances (NCRs), change controls, and internal audits. Applicants must have previous experience working with QMS processes within the Complementary Medicines, Pharmaceutical, Food, or other regulated manufacturing industries.

n

Investigate quality events arising from Quality Management System (QMS) processes, including deviations, customer complaints, non-conformances (NCRs), and audit findings, to identify root causes and implement effective corrective and preventive actions (CAPAs).

n

Perform trend analysis of customer complaints and other quality events to identify recurring issues, assess risks, and implement appropriate CAPAs to drive continuous improvement.

n

Monitor and coordinate the timely closure of Quality Management System (QMS) events, ensuring actions are completed effectively and within required timeframes.

n

Draft, review, and maintain raw material specifications, finished product specifications, and "free from" statements in line with TGA and regulatory requirements.

n

Conduct supplier and vendor assurance activities for raw materials and packaging components.

n





Review and approve product labels to ensure compliance with ARTG listings, regulatory requirements, and internal procedures.

n

Create, review, and maintain Bills of Materials (BOMs) within company software systems.

n

Perform and verify potency calculations for active ingredients and raw materials.

n

Conduct in-process quality checks during manufacturing and packaging operations, including granulation, compression, coating, encapsulation, powder and liquid manufacturing, blister packing, bottle packing, and pouch filling.

n

Draft, review, and maintain Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) in accordance with GMP, product specifications, and TGA requirements.

n

Prepare and review Product Quality Reviews (PQRs) and support ongoing product lifecycle management.

n

Support the QA Manager in maintaining and continuously improving quality systems, SOPs, GMP compliance, and quality culture across the business.

n

Participate in internal audits, regulatory inspections, and quality improvement initiatives as required.

📌 Quality Assurance Officer (City of Gold Coast)
🏢 BJP Laboratories
📍 City of Gold Coast