• Ensure compliance with local and international pharmaceutical regulatory requirements (e.g., TGA, FDA, EMA).
• Conduct internal audits and support external audits by regulatory agencies.
• Monitor and maintain the company's Quality Management System (QMS).
• Review and approve batch records, ensuring adherence to Good Manufacturing Practices (GMP).
• Handle deviations, CAPAs (Corrective and Preventive Actions), and change controls.
• Assist in the development and implementation of quality policies and standard operating procedures (SOPs).
• Work collaboratively with cross-functional teams, including production, R&D, and supply chain, to ensure product quality.
• Conduct training sessions on quality assurance and GMP compliance for staff.

Qualifications and Skills:

• Bachelor’s degree in pharmaceutical sciences, biotechnology, or related field.
• Minimum of 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry.
• Strong knowledge of GMP and regulatory requirements (TGA, FDA, EMA).
• Experience with QMS and CAPA management.
• Excellent attention to detail and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Proficiency in Microsoft Office and quality management software.

Why Join Us?

• Opportunity to work with a leading pharmaceutical company in Australia.
• Competitive salary and benefits package.
• Career growth and development opportunities.
• Supportive and inclusive work culture.

Join Us: If you are a dedicated and highly motivated QA specialist with a passion for ensuring the highest quality and compliance standards, we encourage you to apply. PharmEng offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Become a part of our team and contribute to the success of our industry-leading solutions.

PharmEng is an equal opportunity employer and welcomes candidates of all backgrounds to apply.