AddressTroy Animal Healthcare is a well-established and growing, privately owned, Australian pharmaceuticals manufacturer. As a Quality Assurance Manager, you will play a pivotal role in upholding and enhancing our commitment to quality and excellence. You will be responsible for ensuring that our products meet all industry standards, comply with regulatory requirements, and consistently deliver the exceptional quality our customers expect. As part of this role, in addition to handling regulatory and technical matters, there’s an exciting opportunity for an individual with a commercial mindset—one who can drive positive change. We’re seeking someone with an improvement-oriented mindset and a proven track record as a problem solver.
About the role
- Comprehensive Quality Assurance Program: Manage a comprehensive Quality Assurance program with continuous improvement in mind.
- Embed a Quality Mindset: Foster a company-wide focus on quality.
- Subject Matter Expertise: Act as a subject matter expert on various quality issues, with a special focus on sterile product manufacturing.
- Audits and Compliance: Manage internal and external audits, ensuring timely delivery of action items.
- Collaboration: Collaborate with cross-functional teams to identify areas for process improvement and product enhancement.
- Leadership in Quality Events: Provide leadership in managing critical quality events such as recalls and complaints.
- Regulatory Compliance: Stay up to date with industry regulations and maintain compliance with GMP/APVMA quality standards.
- Validation Master Plan: Execute and regularly review the validation master plan.
- Workforce Training: Develop and deliver training programs to align the workforce with quality objectives.
- Regulatory Liaison: Interact with relevant national and international regulatory bodies.
What we are looking for
- Bachelor’s Degree: Hold a degree in Chemistry, Pharmacology, or another relevant scientific or engineering field.
- Experience: Have at least 5 years of experience in a senior Quality Assurance role, ideally within a pharmaceutical manufacturing environment.
- Sterile Product Knowledge: Possess intimate knowledge of and experience with the manufacture of sterile pharmaceutical products and accompanying regulations.
- Relationship Building: Demonstrate the ability to build strong working relationships, effective communication, and leadership through influence.
- Analytical Skills: Analyse non-conformances, identify root causes, and apply corrective actions.
- Problem-Solving: Exhibit excellent problem-solving abilities.
- Deadline-Driven: Proven ability to work in a fast-paced environment and meet deadlines.
If this sounds like you, please apply via seek. If you have questions email *********@troylab.com.au
