QA & Microbiology Manager – GMP & Regulatory

Pact Group Holdings Ltd; Sydney; On-site; AUD 140,000 - 200,000; Full time

Job summary

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead QA/QC, microbiology and regulatory compliance within a complex manufacturing site.

You will oversee the Quality Management System, environmental monitoring, CAPA and audits while guiding a technical team of QA/QC technicians and microbiologists to ensure products meet customer and regulatory requirements.

Qualifications

• Bachelor's degree in Pharmacy with Pharmaceutics and Microbiology majors specified in the position description.
• Experience in a TGA-regulated manufacturing environment.
• Strong GMP knowledge and experience.
• Experience leading QA/QC and microbiology teams.
• Ability to drive audits and CAPA processes.

Responsibilities

• Lead and continuously improve the site Quality Management System (QMS).
• Drive GMP compliance across manufacturing operations 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 key site certifications and licences, including TGA-GMP, ISO 22716, BRC, APVMA, ACO, RSPO and EPA requirements.
• Participate in validation of manufacturing systems and processes.
• Prepare and authorise Product Quality Reviews (PQRs) where required.
• Lead, coach and develop QA/QC and microbiology team members and build quality capability across the broader site.

Skills

QA leadership

Microbiology

Regulatory compliance

GMP knowledge

Problem solving

Communication skills

Team leadership

Education

Bachelor's degree in Pharmacy

Job description

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead QA/QC, microbiology and regulatory compliance within a complex manufacturing site.

You will oversee the Quality Management System, environmental monitoring, CAPA and audits while guiding a technical team of QA/QC technicians and microbiologists to ensure products meet customer and regulatory requirements.