Quality Assurance Officer

About the role

Join a leading pharmaceutical manufacturer delivering solid dose complementary medicines. You will work within the QA team to ensure product quality and manage TGA GMP standard QMS systems across local and China sites.

Key responsibilities

• Perform release of bulk, finished products and components, issuing CoA and CoC.
• Release batch records to manufacture and manage batch documentation.
• Draft, review and approve SOPs, specifications and product specifications.
• Maintain ERP codes and Bills of Materials.
• Investigate and document customer complaints, non‑conformances, deviations, change controls and CAPAs.
• Assist in preparing annual Product Quality Reports and support vendor assurance activities.

Required profile

• Minimum 3 years experience in a regulated GMP environment.
• Working knowledge of PICs GMP, TGA GMP guidance and standards for AUST L and OTC medicines.
• Experience performing batch release and quality investigations.
• Understanding of PQR and vendor assurance requirements.
• Strong written and verbal communication with cross‑functional teams.
• Degree or Diploma in Science or related field is desirable.

Required skills

• GMP compliance and TGA GMP standards.
• Batch release procedures.
• ERP system usage.
• QMS management.
• CAPA handling.

What we offer

• $90,000 plus superannuation, permanent full‑time role.
• Immediate start preferred with opportunities for career advancement.
• Collaborative environment across local and international sites.