Quality Assurance Specialist

3 days ago

Gold Coast, Queensland, Australia BJP Laboratories Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate to join our team at BJP Laboratories. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities
  • Product Quality Reviews (PQR): Conduct thorough reviews of our authorized medicinal products to ensure compliance with PIC/S guidelines and TGA requirements.
  • Quality Management System (QMS): Oversee and maintain our QMS, ensuring that all quality-related activities are properly documented, deviations are investigated, and corrective/preventive actions (CAPA) are implemented.
  • Vendor Assurance: Manage supplier qualification, approval, and ongoing assessments to ensure vendor compliance with GMP and quality standards. Conduct audits, reviews, and risk assessments for existing and new suppliers.
  • Regulatory Compliance: Ensure all activities align with TGA, PIC/S, and GMP requirements. Provide support during regulatory inspections and audits by maintaining up-to-date documentation and readiness.
  • Process and Documentation Control: Monitor and control the integrity of manufacturing and testing documentation to meet both internal and external audit requirements. Maintain comprehensive records, including non-conformance investigations, change control processes, and CAPA documentation.
  • Continuous Improvement: Work closely with cross-functional teams, including production, engineering, and quality control, to identify areas for process improvement. Implement quality initiatives to enhance efficiency, product safety, and regulatory compliance.
  • Training and Support: Provide GMP, quality systems, and compliance training to internal teams, ensuring adherence to relevant guidelines and continuous professional development.
Requirements
  • Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
  • 2-3 years of experience in Quality Assurance within a pharmaceutical manufacturing environment.
  • Strong understanding of TGA regulations, PIC/S guidelines, and GMP practices.
  • Experience with managing QMS systems, including document control, non-conformance investigations, and CAPA.
  • Familiarity with vendor assurance programs, including supplier qualification and audits.
  • Excellent organizational skills, attention to detail, and the ability to manage multiple tasks simultaneously.
  • Strong communication skills, both written and verbal, and ability to work collaboratively with cross-functional teams.

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