QA Associate - Supplier Auditor

Breathe Life Sciences PTY; Brisbane; Presencial; AUD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Superannuation

Employee benefits package

Meadowbrook facility

Descripción de la vacante

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,

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Supplier management

Auditing

Educación

Chemistry / Pharmacy / Biochemistry / Microbiology degree

Descripción del empleo

QA Associate – Supplier Auditor

Breathe Life Sciences | Meadowbrook, QLD | Full-time, permanent | On-site with domestic & occasional international travel

About Breathe Life Sciences

Breathe Life Sciences (BLS) is an Australian pharmaceutical manufacturer operating from a purpose-built GMP facility at Meadowbrook, Queensland. Our portfolio of prescription medicines, including medicinal cannabis, is supplied under TGA registration and the Special Access and Authorised Prescriber pathways. We are growing a quality team that takes compliance seriously and treats patients as the reason the work matters.

About the role

We are hiring a QA Associate – Supplier Auditor to own our Supplier (and Customer) Audit Programme end to end — from planning the schedule, to running virtual and on-site audits, to driving the corrective actions that keep our supply base compliant.

You will be the person who decides, on paper and in person, whether a supplier of APIs, raw materials, excipients, packaging, labels, laboratory services or distribution meets the standard we need to put product into patients. You will also audit customers who supply us with APIs or other materials, applying a supplier-equivalent protocol. You will report to the QA Manager and work closely with the Head of Quality, Regulatory Affairs and Production.

This is a hands‑on, largely autonomous role for someone who is confident reading TGA requirements and the PIC/S Guide to GMP, forming a view, and defending it.

What you’ll do

Plan and execute the risk-based supplier and customer audit programme, scheduling and running virtual (desktop/remote) and on‑site audits.

Audit suppliers of APIs, raw materials, excipients, packaging, labels, laboratory testing providers, distribution and wholesale partners, and other GMP and non‑GMP service providers.

Qualify, re‑qualify and monitor suppliers under our Supplier Management SOP: review GMP/GACP licences, ISO certifications, supplier questionnaires, specifications, stability data and QMS evidence; assess criticality; recommend approval status.

Draft, negotiate and maintain Quality, Technical and Service Agreements with suppliers and customers.

Write clear, defensible audit reports; classify findings; manage supplier CAPAs to closure; follow up with evidence verification.

Monitor supplier performance (incoming goods rejections, OOS/OOT, deviations, complaints, on‑time delivery) and feed trends into Management Review and Product Quality Reviews.

Maintain the Approved Supplier List and Approved Customer List, and keep supplier profiles current in Dot Supplier Quality.

Support internal audits, self-inspection, deviation and CAPA activities as part of the broader QA team.

About you

A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or related science (advanced degree a plus).

1–3+ years in pharmaceutical, biotechnology or medicinal cannabis quality, with demonstrable supplier management and/or auditing experience.

Formal auditor training — ISO 19011 Lead Auditor or PIC/S/GMP Auditor — is highly desirable; a track record of leading supplier audits is essential.

Confident, current working knowledge of TGA requirements, PIC/S Guide to GMP, ICH Quality Guidelines and the TGOs that apply to our products (TGO 93, 112 and 113). Familiarity with GACP for medicinal cannabis and international frameworks (EU GMP, MHRA, Health Canada DEL, SAHPRA, NZ GMP, Israel GMP) is a plus.

Fluent written and spoken English, with the credibility to run a closing meeting with a supplier’s senior management team.

Able to work independently — you manage your own audit schedule and finding closures, and you are comfortable making the first-call compliance judgement.

Willing and able to travel domestically, and occasionally internationally, for on‑site audits.

Full working rights in Australia.

What we offer

A role with real scope — you own the audit programme end to end, not a slice of it.

Exposure across the full supply chain and a diverse pharmaceutical product portfolio.

A quality team led by experienced GMP practitioners who will back your judgement.

Competitive salary and superannuation; employee benefits package.

Modern Meadowbrook facility, flexible approach to work where the role allows.

Breathe Life Sciences is an equal‑opportunity employer. We welcome applications from candidates of all backgrounds.

All offers are subject to pre‑employment checks, including right‑to‑work verification and, given the Schedule 8 product environment, criminal history and reference checks.

Shortlisted candidates only will be contacted. No agencies, please.