PharmEng is a leading Pharmaceutical and Biopharmaceutical Consulting company committed to delivering innovative solutions for our industries challenges. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are seeking a highly skilled and motivated QA Specialist  to join our team.

Job Title: Quality Assurance Specialist
Location: Melbourne, Australia
Employment Type: Full-Time/Contract

Key Responsibilities:

• 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.