QA Auditor: Supplier & Customer Compliance Lead

Breathe Life Sciences PTY; Brisbane; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Superannuation

Employee benefits package

Meadowbrook facility

Job summary

Breathe Life Sciences is hiring a QA Associate – Supplier Auditor to own the supplier and customer audit programme end to end, from planning to on-site audits, driving CAPAs and ensuring GMP compliance. The role reports to the QA Manager and involves working across QA, Regulatory Affairs and Production in Meadowbrook, QLD.

The ideal candidate has 1–3+ years in pharmaceutical quality with supplier auditing experience, formal auditor training, and strong knowledge of TGA and PIC/S GMP guidelines,

Qualifications

• 1–3+ years in pharmaceutical quality with supplier management or auditing experience.
• Formal auditor training (ISO 19011 Lead Auditor or PIC/S/GMP Auditor) is highly desirable; track record of leading supplier audits.
• Familiarity with TGA requirements, PIC/S GMP, ICH Guidelines and TGOs (TGO 93, 112, 113).
• Fluent written and spoken English.
• Willing and able to travel domestically, and occasionally internationally.

Responsibilities

• Plan and execute the risk-based supplier and customer audit programme, scheduling and running virtual and on-site audits.
• Audit suppliers of APIs, raw materials, excipients, packaging, labels, laboratory services or distribution; monitor compliance.
• Draft, negotiate and maintain Quality, Technical and Service Agreements with suppliers and customers.
• Write clear audit reports; classify findings; manage supplier CAPAs to closure; evidence verification.
• Monitor supplier performance and feed trends into Management Review and Product Quality Reviews.
• Maintain Approved Supplier List and Approved Customer List in the QA system.
• Support internal audits, deviation and CAPA activities.

Skills

Supplier management

Auditing

Education

Chemistry / Pharmacy / Biochemistry / Microbiology degree

Job description

Breathe Life Sciences is hiring a QA Associate – Supplier Auditor to own the supplier and customer audit programme end to end, from planning to on-site audits, driving CAPAs and ensuring GMP compliance. The role reports to the QA Manager and involves working across QA, Regulatory Affairs and Production in Meadowbrook, QLD.

The ideal candidate has 1–3+ years in pharmaceutical quality with supplier auditing experience, formal auditor training, and strong knowledge of TGA and PIC/S GMP guidelines,