Quality Assurance Specialist

3 weeks ago

Sutherland Shire, Australia Bayside Group Full time

The Opportunity:

Bayside Group is seeking a highly skilled Quality Assurance Specialist to join their dynamic team in Sydney's south. As a national organisation manufacturing medicines for a global market, they are at the forefront of their field and committed to regulatory excellence, safety, and continuous improvement within nuclear medicine.

Key Responsibilities:

  • Assess and document compliance with regulatory requirements, including collating information and preparing and submitting quarterly reports to regulatory authorities.
  • Provide technical expertise in licensing, safety, and compliance activities, liaising with regulatory authorities and ensuring adherence to WHS requirements.
  • Facilitate and coordinate timely responses to regulatory issues and ensure effective control and integration of safety and licensing activities.
  • Maintain up-to-date knowledge of safety cases, industry best practices, and regulatory frameworks within nuclear medicine.
  • Contribute to the Business Management System as an internal auditor, supporting documentation revisions and maintenance.
  • Build relationships with regulators and stakeholders, prioritising tasks effectively to meet deadlines.
  • Support nuclear medicine's emergency and business resilience planning, ensuring safety performance indicators are regularly reported.

Benefits:

  • Join an organisation with a reputation for delivering outcomes that make a difference in the lives of Australians.
  • Site-based with some flexibility for hybrid work arrangements.
  • Competitive salary and conditions.
  • Generous employee benefits.

Requirements:

  • Degree in Engineering or Science or equivalent experience.
  • Ability to assess and advise on licensing and regulatory requirements for various operational and engineering activities.
  • Strong focus on compliance.
  • Understanding of AS 4801, ISO 9001, and ISO 14001 standards.
  • Outstanding stakeholder engagement capabilities.
  • Strong communication, negotiation, technical writing, and project management skills.
  • Familiarity with Australian nuclear regulatory frameworks and safety management systems would be highly advantageous.

Special Requirements:

  • Australian citizenship.
  • Must meet Security and Medical clearance requirements.
  • Some interstate travel required.

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