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.
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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.
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Key Relationships:
● Quality Control
● Manufacturing and Packaging Operations
● Regulatory Affairs
● Product Development
● Supply Chain
● TGA Inspectors and third-party auditors
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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.
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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.
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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.
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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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