Production Quality Assurance Specialist

2 weeks ago


Braeside, Victoria, Australia Fuse Recruitment Full time

Job Summary

Fuse Recruitment is seeking a highly skilled and motivated Production Quality Assurance Specialist to join our team. As a Junior Production Team Lead, you will play a crucial role in ensuring the highest standards of quality and compliance in our production processes.

Key Responsibilities

  • Oversee batch-related details, including sterilization charts, Batch Records, and Environmental Monitoring for Non-Viable Particles.
  • Ensure proper labelling and packaging, while supporting a range of quality and compliance activities.
  • Review and sign off on Sterilisation charts and Filter Integrity test results.
  • Assist in reviewing completed Batch Records and related production records.
  • Download and verify Non-Viable Particle data.
  • Ensure and check for label accuracy, carton and batch details as well as product reconciliation at each stage of production.
  • Support operator training.
  • Update batch records and other production/process SOPs/OIs.
  • Contribute to and assist with the execution of the Quality system, including Deviations, Investigations, CAPA, and Change Control reports.

Requirements

  • Previous experience in the pharmaceutical industry (GMP) in Production, QA, or Validation.
  • Tertiary degree in Science, Pharmacy, or a related field.
  • Excellent oral and written communication skills.
  • A humble team player with a flexible and collaborative attitude.
  • Willingness to perform a variety of tasks and work with multiple departments.
  • Demonstrated ability to adapt in a dynamic, small company environment.


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