Pharmaceutical Quality Assurance Specialist

4 days ago

Perth, Western Australia beBeeQualification Full time $90,000 - $120,000
Regulatory Compliance Specialist

We are seeking a qualified specialist to join our team in Western Australia.

About the Role

This position is pivotal in ensuring that our manufacturing processes and analytical methods comply with regulatory requirements and industry standards. The successful candidate will be responsible for maintaining our high-quality assurance standards, leading qualification studies for equipment and systems, and overseeing compliance of computerised systems per regulatory requirements.

Your Key Responsibilities:
  • Lead qualification studies for manufacturing/testing equipment and systems.
  • Oversee the qualification of critical systems such as HVAC, water, and computerised systems.
  • Manage the qualification for manufacturing, packaging, and cleaning processes.
  • Validate analytical techniques, including UPLC and HPLC.
  • Ensure compliance and qualification of computerised systems per regulatory requirements.
Requirements
  • Bachelor's degree or higher in Science, Engineering, or Pharmacy, or a related field.
  • Previous experience in validation or quality assurance roles within the pharmaceutical industry.
  • Excellent organisational skills with the ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving abilities with acute attention to detail.
  • Effective communication skills, both written and verbal, with the ability to collaborate across departments.
What We Offer
  • A competitive salary package.
  • The opportunity to work in a dynamic and innovative environment with cutting-edge technology.
  • Ongoing professional development and career growth opportunities.

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