Junior Quality Associate – Quality Systems

The Junior Quality Associate – Quality System is responsible for supporting the development, implementation, and continuous improvement of the Quality System in accordance with TGA regulations, PIC/S GMP guidelines, and internal quality standards. This position will work closely with the Senior Quality Associates in maintaining GMP compliance and ensuring the quality and safety of products released to the market.

Key Responsibilities:

Maintain and improve site Quality system in line with PIC/S Guide to GMP (PE009), Annexes, and TGA requirements.

Support the development and continuous improvement of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality Manuals.

Support the implementation of Quality Risk Management principles throughout the Quality system.

Support investigations for deviations, non-conformances, and product complaints.

Ensure effective root cause analysis and implementation of Corrective and Preventive Actions (CAPAs).

Track and trend deviation/CAPA metrics and escalate recurring issues.

Evaluate, assess, and coordinate changes impacting the quality system, processes, or products.

Support site readiness for internal, TGA, and third-party audits.

Participate in or lead internal audits as per the site audit schedule.

Assist in the preparation of audit responses and track commitments to completion.

Support GMP training programs for quality and manufacturing staff.

Identify quality system gaps and support initiatives for improvement.

Participate in quality improvement projects across cross-functional teams.

Support Quality Assurance activities.

Key Relationships:

Quality Control

Manufacturing and Packaging Operations

Regulatory Affairs

Product Development

Supply Chain

TGA Inspectors and third-party auditors

Qualifications & Experience:

Essential:

Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or related scientific discipline.

Minimum 2 years’ experience in Quality Assurance within a TGA-licensed pharmaceutical or complementary medicines facility.

Strong knowledge of PIC/S Guide to GMP, TGA regulations, and Australian regulatory environment for complementary medicines.

Proven experience in quality systems, deviations, CAPA, and documentation control.

Familiarity with complementary medicine regulations under the Therapeutic Goods Act 1989

Desirable:

Experience with electronic Quality Management Systems (eQMS).

Lead auditor training or internal auditing experience.

Key Competencies:

Strong attention to detail and analytical mindset.

Effective written and verbal communication skills.

Ability to prioritise and manage multiple tasks under time constraints.

High level of integrity and commitment to compliance.

Proactive approach to problem-solving and continuous improvement.

Performance Measures:

Compliance with internal SOPs and regulatory requirements.

Timely closure of deviations, CAPAs, and change controls.

Audit readiness and minimal audit findings.

Quality System effectiveness and improvements delivered.

Work Environment:

This role is primarily site-based, operating within office and GMP facility environments. Occasional extended hours may be required.