Senior Quality Associate – Pharmaceutical Quality System

1 week ago

Gold Coast, Queensland, Australia Specialty Probiotics Australia Full time $90,000 - $120,000 per year
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.

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