Senior Quality Assurance Specialist

3 weeks ago

Melbourne, Victoria, Australia Evolve Scientific Full time

About Evolve Scientific and the Role:

We are seeking a Senior Specialist to join our Site Inspections and Compliance team.

Key Responsibilities:

  • Provide support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements.
  • Identification and assessment of risks and facilitation of appropriate mitigations to ensure compliance and continuous improvement.
  • Participation in regulatory inspections at Seqirus, including providing responses to regulatory authorities in a timely manner.
  • Maintenance of processes, procedures, and SOPs for auditing and inspections to improve audit readiness.
  • Collaboration with global colleagues to support the harmonization, maintenance, and application of global audit strategy, processes, and SOPs.
  • Stay up to date with industry and regulatory trends to ensure compliance and continuous improvement.
  • Participation in local Quality Management Review and KPI preparation.

Requirements:

  • Tertiary education in a scientific discipline.
  • Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry.
  • Experience as an auditor in internal and external audits.
  • Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations (preferred).
  • Knowledge of global cGMP regulations and ISO standards.
  • Excellent written and oral communication skills.
  • Ability to understand data sets and drive data-based decisions.
  • Excellent problem-solving skills and time management.

Applicants should submit a cover letter and detailed resume in Word format (PDFs can be corrupted/not processed). For more information, contact Evolve Scientific's HR department.

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