Senior Quality Assurance Specialist - Hybrid GMP/Regulatory

Healthcare Professionals Group; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work arrangement

Opportunity to drive Quality improved/

Job summary

Healthcare Professionals Group in Sydney is seeking a Senior Quality Assurance Associate to join a collaborative Quality team. Reporting to the Quality Manager, you will support GMP compliance, contract manufacturing oversight and quality improvement initiatives across the Australian business.

You will take ownership of quality activities, strengthen relationships with external manufacturers and help implement local processes aligned with Australian regulatory requirements.

Qualifications

• 3 years' experience in QA within pharma, devices, or a related regulated industry.
• Strong GMP and Australian TGA knowledge.
• Experience working with external contract manufacturers.
• Hands-on experience in Quality investigations, CAPA and validation activities
• 50

Responsibilities

• Support QA oversight across external contract manufacturers.
• Lead quality investigations, non-conformances and CAPA.
• Coordinate validation activities to GMP and regulatory standards.
• Support stability programs and broader QA activities.
• Review and implement QA procedures aligned with Australian TGA.
• Identify opportunities to streamline processes and improve local QA systems.
• Collaborate with Regulatory Affairs, Commercial and Operations on QA implementation.
• Develop and deliver QA training and workshops.

Skills

GMP knowledge

TGA regulatory

CAPA management

Quality investigations

SOP development

Stakeholder engagement

Training delivery

CM oversight

Education

Science/Pharmacy degree

Job description

Healthcare Professionals Group in Sydney is seeking a Senior Quality Assurance Associate to join a collaborative Quality team. Reporting to the Quality Manager, you will support GMP compliance, contract manufacturing oversight and quality improvement initiatives across the Australian business.

You will take ownership of quality activities, strengthen relationships with external manufacturers and help implement local processes aligned with Australian regulatory requirements.