Senior Quality Professional

2 weeks ago

Bankstown, Australia beBeeQuality Full time $120,000 - $170,000

We are seeking a seasoned Quality Associate to join our professional team. Reporting to the Head of Quality, this role is primarily responsible for supporting the management of quality systems ensuring continued compliance with regulatory requirements.

About the Role

This key position will be involved in the creation and review of controlled documentation including procedures, work instructions and training. Additionally, they will assist in developing and implementing quality systems, reviewing and approving change proposals and related documentation for compliance with regulatory approvals and GMP requirements.

Key Responsibilities
  1. Quality System Management: Support the management of medical device / pharmaceutical Quality Management System ensuring continued compliance with relevant regulations, guidelines and industry standards.
  2. Documentation Control: Creation, review and approval of controlled documentation - assist in development and implementation of quality systems including writing, and review, of procedures and work instructions and training.
  3. Change Proposal Management: Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements.
  4. Investigation and Resolution: Investigation and management of non-conformances, CAPAs, deviations and complaints.
  5. Audit Management: Assistance with audit findings and audit management.
  6. Cross-functional Collaboration: Cross-functional support of design and manufacturing and including analysis of capabilities, controls, sampling, calibration, validation, risk assessment, etc.
  7. Routine QA Duties: Conduct of other routine QA duties such as issue and review of batch documentation, incoming and finished goods release.
Requirements

To be successful in this role, you will need:

  • Education: University degree in Science, Engineering or equivalent.
  • Experience: At least four years' experience in GMP within Pharmaceuticals, Medical Devices or related field. At least two years' experience in a QA role.
  • Skills: High level of verbal and written communication and numeracy skills. Thorough knowledge of standards and governing bodies. Excellent problem-solving skills. Proficient attention to detail, excellent written and verbal communication skills. Ability to work as part of a team.

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