Senior Auditor - Audit and Inspection Management


Location: Parkville

Job Type: Full time


Job Description

The Opportunity

We are looking for a Senior Auditor to join the Audit & Inspections Management team on 2 years Fixed Termbasis. Reporting to the manager of the Audit and Inspections team and part of our Global Quality Systems and Compliance portfolio, you will be responsible for aspects of audit and inspection management activities.

You will provide quality oversight for internal sites and suppliers. You will be onsite at Parkville Location #LI-Onsite

The Role

  • Providing support for the preparation and execution of supplier and internal audits to verify compliance with global GMP regulations and corporate requirements;
  • The identification and assessment of risks and facilitating appropriate mitigations to ensure compliance and continuous improvement;
  • Participate and support Regulatory inspections at Seqirus sites, including providing responses to regulatory authorities promptly;
  • Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness;
  • Working with global colleagues to support the harmonization, maintenance and application of global audit strategy, processes, and SOPs to improve consistency across the manufacturing sites.
  • Maintain and share knowledge of Regulations by staying up to date with industry and regulatory trends to ensure compliance and continuous improvement.

Your skills and experience

  • Bachelor's degree in science discipline, Advanced degree highly regarded
  • Minimum of 3 years in quality or manufacturing experience in regulated industry, in the biotech or pharmaceutical industries;
  • Experience as an auditor, internal/external
  • Experience in sterile product manufacturing, biological processes, and laboratory operations;
  • In-depth knowledge of the regulatory environment for the manufacture of drugs;
  • Knowledge of global cGMP regulations and ISO standards;
  • Experience in audit/inspection management and processes.

How to Apply

Applications must include a CV and cover letter. Applications will close on 2nd of June 2023

Benefits to You:

At CSL, we encourage you to make your well-being a priority. We offer great benefits packages, comprehensive benefits packages, and opportunities for career growth. You will work in a diverse environment where you can make a difference in people's lives through innovation.

About CSL:

CSL is a leading global biotechnology company that has been motivated by our promise to save lives through innovation since 1916. We have a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, and vaccines to prevent influenza. As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

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