compliance and quality expert (pharmaceutical sector) in Melbourne CBD

posted
contact
richard hunter, randstad
job type
temporary
apply now

job details

posted
location
melbourne cbd, victoria
specialism
life sciences & pharma
job type
temporary
working hours
Full-Time
reference number
90M0374979_1549329039
contact
richard hunter, randstad
apply now
Apply with

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.

skills

Compliance and Quality Expert (pharmaceutical sector)

qualification

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