Senior Quality Associate

About this opportunity

The Senior Quality Associate is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with GMP requirements regulatory obligations customer expectations and internal quality standards.

Working closely with the Quality Manager and other departments the role supports the management of quality systems including deviations CAPAs change controls customer complaints supplier quality and validation activities audits training and inspection readiness. The position also contributes to continuous improvement initiatives and helps to promote a proactive quality culture across the business.

The Senior Quality Associate collaborates with internal teams customers suppliers and regulatory authorities to support product quality patient safety and ongoing compliance. When required the role may act as a delegate for the Quality Manager supporting day-to-day quality activities and ensuring continuity of quality operations.

Your key responsibilities will be to:

• Manage and continuously improve the Pharmaceutical Quality System (PQS) ensuring compliance with GMP GXP TGA PIC/S FDA customer and corporate requirements.
• Maintain and control quality documentation including SOPs specifications forms quality records and change control processes.
• Lead investigations into deviations non-conformances complaints and audit findings using risk-based decision-making and root cause analysis methodologies.
• Develop implement monitor and verify the effectiveness of Corrective and Preventive Actions (CAPAs) to drive sustainable quality improvements.
• Monitor quality KPIs trends and metrics providing insights and recommendations to support continuous improvement initiatives.
• Conduct and coordinate internal audits self-inspections supplier assessments and audit remediation activities ensuring actions are closed out effectively.
• Support customer audits and regulatory inspections maintaining a high level of site inspection readiness at all times.
• Participate in quality risk assessments and support the implementation of risk-based approaches to reduce compliance and operational risks.
• Support supplier qualification and approval activities including the review of supplier documentation quality agreements and ongoing performance.
• Review batch documentation and support batch disposition product release activities and management reporting where required.

Your skills and experience

To be successful in this role youll have:

• A Bachelors degree in Science Pharmacy Chemistry Microbiology Chemical Engineering or a related discipline.
• At least 5 years experience in Quality Assurance within a GMP-regulated pharmaceutical or therapeutic manufacturing environment.
• Strong knowledge of Pharmaceutical Quality Systems and regulatory requirements including GMP TGA PIC/S and relevant industry standards.
• Hands-on experience managing quality systems including deviations CAPAs change controls investigations complaints and document control.
• Experience supporting customer audits regulatory inspections and internal audit programs.
• Sound understanding of root cause analysis risk assessment and problem-solving methodologies.
• Proven ability to review and approve GMP documentation with a high level of accuracy and attention to detail.
• Strong communication and stakeholder management skills with the ability to build effective relationships across all levels of the organisation.
• Excellent organisational skills and the ability to manage multiple priorities in a fast-paced manufacturing environment.
• A proactive solutions-focused mindset with strong analytical skills sound judgement and a commitment to continuous improvement.

Desirable

• Experience working within a Contract Manufacturing Organisation (CMO) environment.
• Knowledge of validation and qualification activities.
• Internal Auditor or Lead Auditor qualification.
• Experience analysing quality data and trends to support decision-making and continuous improvement initiatives.

Additional Information :

About us

Our vision is to lead the circular economy through packaging reuse and recycling solutions. Its a future-driven group commitment designed to create lasting value.

Were the largest plastics recycler in Australia and New Zealand and one of the regions biggest user of recycled materials. We have 6000 team members operate 110 manufacturing facilities across 15 countries and our customers include some of the worlds largest brands that consumers know and trust.

As a global leader in circular and sustainable packaging solutions weve committed to lead the circular economy through a $500 million investment plan. 

For us its about finding new and better ways of doing things. Ways to grow business to give back to the environment and to enrich peoples lives every day.

Our promise is to create a better and more prosperous world all round.

Thats our future Pact. Lets lead the way together.

Remote Work :

No

Employment Type :

Full-time