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Senior Auditor, Asia Pacific - Quality Assurance

Employer
CSL - Australia
Location
Broadmeadows, AU
Salary
Competitive
Start date
19 Apr 2021
Closing date
3 May 2021

View more

Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

  • Work in Global position and team | Be part of a significant growth at CSL
  • ASX Top 5 | Australia's largest pharmaceutical manufacturing site
  • Full Time, Permanent Position | based in Broadmeadows | On-Site Parking


Our Culture
At CSL, we are driven by our promise to stakeholders, including our employees. CSL is committed to building a workplace where employees can have Promising FUTURES by fulfilling their career aspirations, realising their potential and being part of a purpose-driven company with a Values-based culture.

Whether you are becoming an expert in your field,moving across, or upward in the organisation, we believe our people can enjoy Promising FUTURES where they fulfil their individual career aspirations and are inspired by our purpose-driven company and values-based culture. Our environment is collaborative, global and dynamic, which fosters innovation and motivates the best and brightest to succeed.

The Opportunity
Reporting into the Associate Director - ESQA (External Supply Quality Assurance), CSL has an exciting position come available for a full-time permanent Senior Auditor in Supplier Qualification.

In this diverse position, you will be collaborating with various external supply chain partners , and will be responsible for assuring that suppliers of raw material, components, operating supplies, and laboratory services conduct their operations in compliance with pharmaceutical industry standards across all CSL Behring sites.

The Role
  • Travels on a routine basis locally and outside Australia to perform quality systems audits of approved and/or potential suppliers of raw materials, components, suppliers and service providers for the CSL Sites. May also perform distributor and CSL affiliate audits, as requested
  • Prepares audit report and assigns levels of compliance to each observe action based on established criteria. Delivers audit results to suppliers in a professional manner. Evaluates supplier corrective action plans are satisfactorily addressing the observation(s)
  • Responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations
  • Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL manufacturing site, service providers and suppliers
  • Assists the manufacturing site as the subject matter expert for Supplier Quality during inspections to mitigate compliance risk to the manufacturing site and to Supplier Quality


Skills and Experience
  • Demonstrated experience in a GxP environment, with strong internal and external auditing knowledge within the pharmaceutical industry
  • Understanding of required local and international regulations including but not limited to: Therapeutics Goods Authority (TGA), Food and Drug Administration (FDA), Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), European regulations, and Canadian Health Authority
  • Strong organisational and communication skills, coupled with the ability to collaborate effectively with external suppliers and stakeholders
  • Exceptional time management and planning skills
  • Previous experience working in a diverse global / matrix organisation would be highly regarded
  • Undergraduate degree in a relevant business or science, or equivalent education and experience


Please note that this position will require extensive local and international travel when it is permissible in the future. During this current climate, remote audits are being substituted for a number of international on-site audits.

How to apply

Apply now to support CSL Behring during next phase of growth! Please include your cover letter and CV in your application. Applications close 5pm AEST on Sunday 2 May, 2021.

As a global organisation with employees in more than 30 countries, CSL embraces diversity & inclusion. It's the foundation of who we are. Diversity and inclusion are critical to our Values of patient focus, superior performance, innovation, integrity and collaboration. As a company, we rely on our people's diverse perspectives, ideas, capabilities and experiences to help us deliver on our promise to our patients, our business and our shareholders.

The Company

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent haemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 70 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring .

Worker Type:
Employee

Worker Sub Type:
Regular

Company

Find out more about working for our company

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Brief Company Description; 

Driven by Our Promise

Delivering on promises is what we do at CSL.

Over a century ago in Melbourne, Australia, we made a promise to save lives and protect the health of people who were stricken with a range of serious and chronic medical conditions. Today, as a leading global biotech company, that same promise has never been stronger. We develop and deliver innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions live full lives. We are driven by our deep passion to serve hundreds of thousands of patients and other stakeholders around the world.

Company info
Website
Mini-site
CSL - Australia
Telephone
+61 3 9389 1911
Location
45 Poplar Road
Parkville
VIC
3052
Australia

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