Quality & Microbiology Leader (GMP, Regulatory)

Pact Group; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead quality, microbiology and regulatory compliance in a complex manufacturing environment.

You will oversee our Quality Management System and onsite microbiological testing activities, while leading a technical team of QA/QC Technicians and Microbiologists, ensuring products meet regulatory and customer requirements.

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.
• Knowledge of microbiological testing and lab quality systems.
• Strong investigative and problem-solving skills.
• Effective communication across technical, operational and leadership teams.

Responsibilities

• Lead and continuously improve the site Quality Management System (QMS).
• Drive GMP compliance across the manufacturing operation and laboratory.
• Maintain compliance with relevant 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).
• Lead, coach and develop QA/QC and microbiology team members.

Skills

GMP knowledge

Quality audits

Microbiology knowledge

Regulatory compliance

Leadership

Problem-solving

Continuous improvement

Communication

Education

Bachelor's degree in Pharmacy

Job description

Pact Contract Manufacturing in Hornsby, NSW, is seeking an experienced Quality Assurance & Microbiology Manager to lead quality, microbiology and regulatory compliance in a complex manufacturing environment.

You will oversee our Quality Management System and onsite microbiological testing activities, while leading a technical team of QA/QC Technicians and Microbiologists, ensuring products meet regulatory and customer requirements.