Kato Laboratories is an Australian owned veterinary pharmaceutical manufacturer committed to the research, development and manufacture of high-quality animal health products for domestic and international markets. Our manufacturing operations comply with GMP requirements and international regulatory standards. Kato is staffed by a small team of skilled professionals.
About the role
We are seeking an experienced Quality Manager to oversee our Quality Assurance and Quality Control functions; ensuring compliance with GMP requirements across the manufacture of veterinary pharmaceutical products; & maintaining regulatory compliance with APVMA, FDA, EMA and international quality standards.
Lead the site’s Quality Management System (QMS).
Monitor GMP compliance throughout manufacturing and laboratory operations for veterinary pharmaceutical manufacturing.
Manage quality assurance procedures ensuring integrity, security and traceability of quality data and records including:
- Document Control
- Batch Release
- CAPA
- Deviations
- Change Control
- Product Quality Reviews
Analyse quality data and metrics to identify trends, areas for improvement, and corrective actions.
Lead investigations into quality issues and non-conformance, determining root causes and implementing preventive measures.
Review and approve validation protocols including:
- Process Validation
- Cleaning Validation
- Equipment Qualification
- Release of Stability Studies and Batch Manufacture documentation.
Establish, document, validate and implement all Quality Control test procedures including sampling, testing, retention samples.
Conduct in-house quality audits to ensure compliance with APVMA, VICH, PIC/S,
FDA and EMA expectations where applicable.
Represent Kato for health authority audits (APVMA/TGA); responsibility for audit documentation and GMP licence of facility.
Mentor and develop staff in QA/QC and continuous improvement methodologies.
Monitor supplier and vendor quality performance to maintain supply chain integrity.
Report on quality metrics and performance indicators to management.
Essential Qualifications
- Bachelor degree: Pharmacy, Chemistry, Pharmaceutical Science or related discipline.
- Minimum 5-10 years within pharmaceutical or veterinary pharmaceutical industry
- Minimum 3-5 years in a Quality Management role.
- Quality Assurance and Quality Systems management.
- Leadership skills & ability to mentor and train team members toward a strong quality culture.
- Excellent problem-solving abilities and a high attention to detail.
- Strong communication and interpersonal skills.
- Proficiency with documentation systems and management of complex quality records.
- Excellent technical writing and documentation skills.
- A proactive approach to continuous improvement and commitment to maintaining the highest quality standards.
- Regulatory compliance and audit readiness: APVMA, TGA and European regulatory.
- Solid working knowledge of: PIC/s GMP; APVMA Manufacturing Principles; VICH Guidelines: ICH Q7; FDA, cGMP requirements; EU GMP; ISO Quality Systems.
What we offer
At Kato Laboratories, we value our employees and offer a supportive and friendly work environment that promotes professional development and work-life balance. We foster a collaborative culture where your contributions are valued, and we encourage innovation and continuous learning.