Quality Assurance Associate

Healthcare Professionals Group; Sydney; On-site; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Broad QA role

Global initiatives exposure

Quality improvement projects

Job summary

Healthcare Professionals Group – Sydney NSW is seeking a quality assurance professional to support day-to-day QA activities across pharmaceutical storage and distribution operations. This varied role involves product release, investigations, audits and continuous improvement, with opportunities to contribute to wider quality initiatives.

Reporting to the Quality Manager, you will review releases, manage temperature excursions and customer complaints, prepare reports and support CAPAs, while

Qualifications

• Tertiary qualifications in a technical discipline, or relevant practical experience.
• Demonstrated experience within the pharmaceutical industry.
• Experience working within GDP and GMP quality management systems.
• Ability to build effective relationships across functions.
• Comfortable working independently and collaboratively, with the ability to adapt to changing priorities.

Responsibilities

• Review and approve product release for distribution, ensuring quality requirements are met and decisions are appropriately documented.
• Investigate temperature excursions and assess their impact on product quality.
• Manage customer complaints and returned product assessments, coordinating investigations and appropriate follow-up actions.
• Prepare quality reports and performance metrics, highlighting trends, risks and improvement opportunities.
• Support quality risk assessments, deviation investigations, root cause analysis and corrective and preventive actions (CAPAs).
• Maintain training records and support the delivery of GDP, GMP and procedural training.
• Participate in internal and external audits, support inspections and follow up on findings.
• Review customer and vendor approvals, maintain records and coordinate periodic reapprovals.
• Support change control, recall management and wider quality improvement initiatives.

Skills

Quality Assurance

GDP/GMP knowledge

Investigations

Documentation

Stakeholder relations

Education

Pharmaceutical Science degree

Tools

Quality systems

Job description

Healthcare Professionals Group – Sydney NSW

• Broad, hands-on quality assurance role within the pharmaceutical industry.
• Exposure to product release, investigations, audits and continuous improvement.
• Contribute to quality improvement projects and global initiatives.

Benefits

• Broad, hands-on quality assurance role within the pharmaceutical industry.
• Exposure to product release, investigations, audits and continuous improvement.
• Contribute to quality improvement projects and global initiatives.

About the company

Our client is a pharmaceutical organisation bringing together specialist expertise and industry partnerships to support the supply of medicines. The business takes a collaborative approach, with teams working across functions to support its customers and partners.

About the opportunity

Reporting to the Quality Manager, you will support day-to-day quality assurance activities across pharmaceutical storage and distribution operations. This is a varied role that combines hands-on operational quality with opportunities to contribute to wider business improvements. You will work across product release, temperature excursions, complaints and quality investigations, while building relationships with internal teams, manufacturers and logistics providers. This opportunity would suit someone who enjoys solving problems, taking ownership of their work and collaborating across different areas of a business.

Duties

• Review and approve product release for distribution, ensuring quality requirements are met and decisions are appropriately documented.
• Investigate temperature excursions and assess their impact on product quality.
• Manage customer complaints and returned product assessments, coordinating investigations and appropriate follow-up actions.
• Prepare quality reports and performance metrics, highlighting trends, risks and improvement opportunities.
• Support quality risk assessments, deviation investigations, root cause analysis and corrective and preventive actions (CAPAs).
• Maintain training records and support the delivery of GDP, GMP and procedural training.
• Participate in internal and external audits, support inspections and follow up on findings.
• Review customer and vendor approvals, maintain records and coordinate periodic reapprovals.
• Support change control, recall management and wider quality improvement initiatives.

Skills and Experience

• Tertiary qualifications in a technical discipline, or relevant practical experience.
• Demonstrated experience within the pharmaceutical industry.
• Experience working within Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) quality management systems.
• Ability to build effective relationships across functions.
• Comfortable working independently and collaboratively, with the ability to adapt to changing priorities.

Culture

Join a quality-focused environment where collaboration and continuous improvement are shared priorities.