Senior Quality Systems Lead

2 weeks ago

Melbourne, Victoria, Australia beBeeQuality Full time

Quality Assurance Specialist Role Summary:

This senior-level position is responsible for leading and managing the Quality System, ensuring compliance with industry regulations and standards. The successful candidate will have a comprehensive understanding of quality management principles and practices.

Job Description:

The Quality Assurance Specialist will be responsible for establishing, developing, implementing, maintaining, and improving quality systems processes and programs, including:

  • Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint)
  • Document Control Program
  • Supplier Qualification
  • Validations
  • Product Transfer

The ideal candidate will possess excellent English written and verbal communication skills, good interpersonal skills, and the ability to work effectively and efficiently in a team environment to accomplish goals.

Required Skills and Qualifications:

University degree in science, nursing or similar, or equivalent work experience in Quality with a minimum of 4 years' experience in QA in the pharmaceutical or medical device industries.

The key to securing this role is a comprehensive understanding of and experience in GMP, TGA requirements, GAPA, Deviations, and ideally you will be certified in internal auditing.

Knowledge of Master Control or similar eQMS is a plus.

Benefits:

A family-friendly, collaborative culture where everyone is working towards a common goal. Be appreciated and valued.

An extremely rewarding role that makes a huge difference to people's lives.

No competitors in Australia, cutting-edge innovation in healthcare.

Others:

As a team member, you will foster cross-functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.

Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.

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