compliance and quality expert (pharmaceutical sector) in Melbourne CBD

richard hunter, randstad
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job details

melbourne cbd, victoria
life sciences & pharma
job type
working hours
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richard hunter, randstad
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job description

We currently hav a 5 month assignment available for a pharmaceutical compliance expert who has experience with GAMP V-Model and 21 CFR Part 11 and other TGA / FDA guidelines.

The role will involve:

  • being part of a large project team implementing SAP and a new LIMS system
  • providing subject matter expertise on pharmaceutical guidelines and regulations
  • providing validation support for SAP
  • participating in some out of hours conference calls at 10pm or 11pm at night with international operations (please note that flexibility is provided in the role)

To be considered you will need to have:

  • significant experience in the lifesciences space and previously worked in a compliance / quality role
  • experience in SAP validation
  • understanding of cGMPS with respect to the TGA, EU and FDA particularly TGA / PIC's Annex 11 and FDA 21 CFR part 11
  • understanding of GAMP5

This is a chance to be part of a high performing project team where the overall consensus from the team members is that this is the best place they have worked. If this sounds like the opportunity for you please click the "APPLY NOW" button.

Job reference number - 90M0374979.

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.


Compliance and Quality Expert (pharmaceutical sector)


Great opportunity for a compliance expert with experience with GAMP V-Model and 21 CFR Part 11 and other TGA / FDA guidelines

educational requirements

Bachelor Degree