QA & Microbiology Manager

About the role

Pact Contract Manufacturing is looking for an experienced Quality Assurance & Microbiology Manager for its manufacturing operation in Hornsby. This is a hands-on quality leadership role, reporting to the NSW Quality Manager, responsible for ensuring products are fit for purpose and meet regulatory, customer and internal quality requirements. The role oversees the Quality Management System and onsite microbiological testing and leads a technical team of QA/QC Technicians and Microbiologists.

Key responsibilities

• Lead and continuously improve the site Quality Management System (QMS).
• Drive GMP compliance across the manufacturing operation and laboratory.
• Maintain compliance with TGA, ISO 22716, APVMA and BRC requirements.
• Manage the QC testing laboratory and onsite microbiological testing activities.
• Lead environmental monitoring and cleaning validation programs.
• Manage investigations, deviations, out-of-specification results and CAPA.
• Review and approve testing data and ensure accurate quality records.
• Lead and coordinate site audits and product recalls.
• Partner with suppliers, customers, auditors, regulatory authorities and external laboratories.
• Maintain site certifications and licences (TGA-GMP, ISO 22716, BRC, APVMA, ACO, RSPO, EPA).
• Participate in validation of manufacturing systems and processes, and prepare and authorise Product Quality Reviews (PQRs) where required.
• Lead, coach and develop QA/QC and microbiology team members.

Required profile

• Bachelor's degree in Pharmacy, with Pharmaceutics and Microbiology majors specified in the position description.
• Quality Management Systems experience in a TGA-regulated manufacturing environment.
• Strong GMP knowledge and experience.
• Experience conducting and supporting quality audits.
• Knowledge of microbiological testing and laboratory quality systems.
• Strong investigation, problem-solving and continuous improvement capability.
• Effective communication across technical, operational and leadership teams, with strong written reporting skills.