QA Technical Specialist

Location: SE Suburbs Melbourne, Victoria
Job Type: Contract or Temp
Contact: Scott Logan

About the company

This global blue chip business has a name that is synonymous with the pharmaceutical industry - an instantly recognisable brand, they have a large and well established network in Australia, developing and producing products that improve the lives of patients in their time of need. This underpins the mission of their business and drives their people to create the best possible outcomes for their stakeholders. Their physical operations are undergoing a period of growth which has created career opportunities for their people, and for them to further expand their QA team.

About the role

The QA Technical Specialist has the responsibility of supporting the site with QA and Validation oversight to ensure that their operations meet critical compliance requirements. This is not a day to day role - you will be influencing and engaging stakeholders across the business in providing QA and Validation advice, utilising the execution skills of junior-mid level resources to complete physical work including documentation, and using your experience to ensure that risks to compliance and GMP are mitigated. Specifically, this means:

  • Oversee and participate in site validation and calibration programs
  • Review and approve validation, risk management and calibration documentation
  • Review and approve deviations, exceptions and CAPAs
  • Ensure the risk assessment program is maintained
  • Scope and implement QA systems to meet compliance and GMP
  • Make data informed decisions to drive continuous improvement for Quality outcomes

About you

We're looking for someone who is a competent and capable QA practitioner in the pharmaceutical industry. You are someone who is motivated and enthusiastic, and ready for a step beyond basic day to day quality roles. You're able to use your experience to identify and mitigate risks before they happen, to understand the broader business implications of your actions and initiatives, and to effectively influence cross-functional teams and stakeholders to improve Quality outcomes across the business. Critical experience for this role includes:

  • Relevant tertiary degree, likely science, engineering or similar
  • QA and validation background within pharmaceutical manufacturing
  • Strong understanding of TGA and FDA regulatory, cGMP requirements
  • Sound QA systems knowledge including aseptic manufacturing processes
  • Proactive and able to handle challenging deadlines across multiple concurrent projects

Why apply?

This role is a step beyond a day to day QA position which means that it is a lot more involved beyond compliance documentation and protocols. You can have a real influence on the improvement of QA practices and systems as a leader in the pharmaceutical sector and to ensure the highest standards for patients that need their products. If you are in a position to consider a role that will initially be a 12 month contract, there is a strong possibility for ongoing employment opportunities as part of a growing company that is investing in physical operations as well as the growth of their teams.

How to apply

Click on the APPLY button or contact Scott Logan for a confidential discussion on 03 8613 3551