Quality Assurance Expert

2 days ago

Adelaide, South Australia beBeequality Full time $140,000 - $170,000

Quality Assurance Expert

We are seeking a highly experienced Quality Assurance Expert to join our dynamic team. As a key member of our management team, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

About the Role:

The successful candidate will have overall responsibility for the quality assurance function, ensuring compliance with GMP, regulatory, and company quality standards. This will involve leading and managing the QA team, overseeing the implementation and continuous improvement of the Quality Management System (QMS), and developing tactical policies, processes, and procedures to meet regulatory requirements.

Responsibilities:

  • Lead and manage the QA function, ensuring compliance with GMP, regulatory, and company quality standards.
  • Oversee the implementation and continuous improvement of the QMS, including SOPs, training, CAPAs, change controls, product complaints, and risk assessments.
  • Develops, implements, prioritises and communicates the site's GMP quality strategy and its GMP quality programs.
  • Ensure QA release of raw materials, packaging, intermediates, and finished products.
  • Maintain inspection readiness and lead/support regulatory, customer, and internal audits.
  • Drive quality performance through monitoring, reporting, and review of key metrics and Product Quality Reviews.
  • Collaborate with Technical Operations and Manufacturing to ensure compliant processes and support New Product Introductions.
  • Provide training and development to staff to build quality capability across the site.
  • Identify and implement quality improvements as part of site continuous improvement initiatives.

Requirements:

  • Tertiary qualifications in a relevant scientific discipline or related field.
  • 10+ years of experience in Quality Assurance in the Pharma industry.
  • Maintain a strong understanding of regulatory requirements in the Pharma industry.
  • Ability to lead internal audits and regulatory agency inspections.
  • Strong technical skills and computer literacy, with excellent communication, problem-solving, and decision-making skills.
  • Highly organised, detail-oriented, and adaptable, with the ability to manage multiple priorities and work autonomously.

Benefits:

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. Our company culture values collaboration, innovation, and excellence, and we strive to create a positive and inclusive work environment that supports our employees' well-being and success.

Our Culture:

We are committed to fostering a culture that is responsive, adaptive, and aligned with our business goals. We believe in promoting diversity, equity, and inclusion, and we strive to create a workplace where everyone feels valued, respected, and empowered to contribute their best.

About Us:

We are a leading player in the pharmaceutical industry, dedicated to delivering high-quality medicines and services to patients around the world. We pride ourselves on our commitment to excellence, our innovative approach to medicine development, and our dedication to making a positive impact on people's lives.

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