Senior QA & Microbiology Leader, GMP & Regulatory

Contract Manufacturing; Sydney; On-site; AUD 150,000 - 180,000; Full time

Job summary

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead the QA/QC and microbiology teams. You will head the Quality Management System, ensuring products meet regulatory and customer quality requirements, and manage microbiological testing onsite.

You will drive GMP compliance across manufacturing and laboratory operations, oversee audits, CAPA, and product recalls, and collaborate with suppliers and regulators to maintain high

Qualifications

• Bachelor's degree in Pharmacy with Pharmaceutics and Microbiology majors.
• Experience in a TGA-regulated manufacturing environment.
• Strong GMP knowledge and experience.
• Experience conducting quality audits.

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, BRC, and related requirements.
• Manage the QC testing laboratory and onsite microbiological testing activities.
• Lead environmental monitoring and cleaning validation programs.
• Manage investigations, deviations, OOS results and CAPA.
• Review and approve testing data and ensure quality records.
• Lead site audits and product recalls, and coordinate with stakeholders.

Skills

Quality leadership

GMP knowledge

Microbiology expertise

QA/QC testing

Regulatory compliance

Audits & CAPA

QMS management

Investigation & problem solving

Education

Bachelor's degree in Pharmacy

Job description

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead the QA/QC and microbiology teams. You will head the Quality Management System, ensuring products meet regulatory and customer quality requirements, and manage microbiological testing onsite.

You will drive GMP compliance across manufacturing and laboratory operations, oversee audits, CAPA, and product recalls, and collaborate with suppliers and regulators to maintain high