R&D Senior Quality Advisor

Job Type:Part Time

About CSL

With operations in 35+ nations and ~ 22,000 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!

Job Description

Assesses, evaluates and reviews results of analytical manufacturing tests and/or reviews manufacturing and release documents to determine if product/material specifications are met. Ensures that established sampling and statistical process control procedures are followed. Identifies and reviews deviations from established standards in the manufacturing and/or packaging of products. Ensures that customer and regulatory requirements are implemented and reviews change accounting activity to ensure compliance. Determines the disposition of materials, semi-finished and finished products. Acts as control checkpoint for final and/or in-process release authorization.

The Opportunity:

We have an opportunity for an R&D Senior Quality Advisor - Quality Systems to join our team in Parkville. This is a 12 month fixed term part-time position. Reporting into the R&D Senior Quality Systems Manager, you will manage the R&D vendors that provide materials and services (including transport and laboratory services) to R&D. You will also ensure regulatory compliance with requirements of the Office of the Gene Technology Regulator (OGTR) & Department of Agriculture (DoA), OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025.

As the R&D Senior Quality Advisor, you will be responsible for the following:

  • Materials management - chair material review board for new product introduction, and facilitate and approve new material creation and changes to existing materials,
  • Quality review of material discrepancies and management of vendor change notifications,
  • Manage, plan and perform OGTR, DoA, GLP, GCLP and facility inspections as per the QA schedule.
  • Perform quality reviews of facility documentation, as well as non-clinical and clinical documentation for R&D GLP and clinical studies.

Skills and Experience Required:

  • A degree in a relevant biological science, with at least three years’ experience in at least one of: manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant process development
  • In-depth understanding of GMP requirements in the pharmaceutical industry and previous production, Quality or R&D experience within the pharmaceutical industry
  • Good interpersonal, negotiation and influencing skills
  • Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL
  • Good analytical and problem solving skills
  • Understanding of the product development process and environment is desirable
  • Ability to work well independently and to self-motivate
  • Well-developed organizational and time management skills
  • Experience with OECD Principles of GLP studies is preferable, but not required

How to Apply:

Applications must address the selection criteria above and include a current CV and covering letter.

Applications close 26th of May 2020

Employment screening, including criminal history, medical assessment, confirmation of experience and stated qualifications, Australian working rights and other relevant checks form part of the candidate suitability