Position Overview:

The Senior Quality Associate – Pharmaceutical Quality System is responsible for supporting the development, implementation, and continuous improvement of the Pharmaceutical Quality System (PQS) in accordance with TGA regulations, PIC/S GMP guidelines, and internal quality standards. This role plays a critical part in maintaining GMP compliance for the manufacture of complementary medicines and ensuring the quality and safety of products released to the market.

Key Responsibilities:

PQS

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

● Lead the development, review, and approval of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality Manuals.

● Support the implementation of Quality Risk Management principles throughout the PQS.

● Perform regular quality reviews to monitor system effectiveness and drive continuous improvement.

● Lead investigations for deviations, non-conformances, and product complaints.

CAPA

● 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.

● Ensure all changes are risk-assessed and implemented in a controlled manner.

Internal and External Audits

● 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.

Training and Compliance

● Support GMP training programs for quality and manufacturing staff.

● Ensure training compliance for PQS-related topics.

Continuous Improvement

● Identify quality system gaps and lead initiatives for improvement.

● Participate in quality improvement projects across cross-functional teams.

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 3–5 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.

● PQS 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 during audit preparation.