Senior Quality Associate – Pharmaceutical Quality System

5 days 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.

  • Quality Associate

    3 days ago

    Gold Coast, Queensland, Australia Unidex Healthcare Full time

    **Quality Associate**:- Great career opportunities- Competitive Salary & commission structure- Based on the Gold Coast, Queensland**About the Company**:Unidex Healthcare are a privately owned recruitment company established in 2001 and operate across Australia, with our main offices in Victoria, New South Wales, South Australia, Northern Territory and...

  • Senior Pharmaceutical Operations Lead

    2 days ago

    Gold Coast, Queensland, Australia beBeeOperations Full time $110,000 - $155,000

    Job OverviewWe are seeking a highly skilled Senior Pharmaceutical Operations Lead to drive excellence across all areas of production and supply. This role will lead our manufacturing operations, driving continuous improvement and ensuring efficiency, compliance, safety, and quality.About the RoleOversight of day-to-day manufacturing operations to ensure...

  • Senior Quality Systems Manager

    7 days ago

    Gold Coast, Queensland, Australia beBeeQuality Full time $90,000 - $120,000

    Job DescriptionThe Quality Assurance Specialist is responsible for maintaining and enhancing quality systems within high-compliance environments.Conduct audits of internal processes and suppliers to ensure adherence to industry standards.Manage environmental sampling and report laboratory results.Perform trend analysis and recommend corrective actions to...

  • Senior Quality Expert

    3 days ago

    Gold Coast, Queensland, Australia beBeeQuality Full time $130,000 - $170,000

    Job DescriptionA senior quality expert is required to lead the quality team across a small portfolio. The successful candidate will work closely with facility managers, quality specialists, and clinical teams to support homes in achieving accreditation.The role involves providing quality support, driving continuous improvement, maintaining clinical...

  • Senior Quality Professional

    1 day ago

    Gold Coast, Queensland, Australia beBeeQuality Full time $100,000 - $150,000

    **Job Overview**We are seeking an experienced quality professional to lead the implementation and continuous improvement of our corporate quality management system.This senior role will drive efficiency and operational performance across our portfolio by ensuring compliance with third-party certification standards and exceeding client-specific...

  • Administration Support Officer

    3 days ago

    Gold Coast, Queensland, Australia Quality People Full time

    **Our client URGENTLY requires an Administration Support Officer for 3 months + Contract in Nerang.**The Administration Support Officer will utilise a broad range of computer software programs and information management systems and databases to carry out duties associated with accounts payable processes and finance-related activities.**Accountabilities...

  • Pharmaceutical Operations Leader

    15 hours ago

    Gold Coast, Queensland, Australia beBeeManufacturing Full time $140,000 - $170,000

    Job Title:Operations ManagerAbout the Role:We are seeking a dynamic and experienced operations leader to drive our manufacturing operations, implement process improvements, and ensure quality across all areas of production.The ideal candidate will have a strong background in pharmaceutical or related regulated manufacturing environments and minimum 7+ years...

  • Operations Manager – Pharmaceutical Cdmo

    19 hours ago

    Gold Coast, Queensland, Australia At Full time

    OverviewOperations Manager – Pharmaceutical CDMOEpsilon Pharma Pty Ltd is part of Epsilon Healthcare. Epsilon Healthcare Limited (ASX: EPN) is an Australian based, globally active healthcare organisation. With a diversified and vertically integrated portfolio of assets, including healthcare, pharmaceutical contract development and manufacture & pharmacy...

  • Operions Manager – Pharmaceutical CDMO

    3 days ago

    Gold Coast, Queensland, Australia at Full time

    OverviewOperations Manager – Pharmaceutical CDMOEpsilon Pharma Pty Ltd is part of Epsilon Healthcare. Epsilon Healthcare Limited (ASX: EPN) is an Australian based, globally active healthcare organisation. With a diversified and vertically integrated portfolio of assets, including healthcare, pharmaceutical contract development and manufacture & pharmacy...

  • Operions Manager – Pharmaceutical CDMO

    2 days ago

    Gold Coast, Queensland, Australia at Full time

    OverviewOperations Manager – Pharmaceutical CDMOEpsilon Pharma Pty Ltd is part of Epsilon Healthcare. Epsilon Healthcare Limited (ASX: EPN) is an Australian based, globally active healthcare organisation. With a diversified and vertically integrated portfolio of assets, including healthcare, pharmaceutical contract development and manufacture & pharmacy...