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Quality Assurance Professional (Temp)

Job description

Summary

My client, a global pharmaceutical company, is looking to a hire an experienced Quality Assurance Professional on a 12 month temporary contract. This is a days role and will report to the Quality Operations Manager. 

 Responsibilities:

  • As a QAP you will have overall responsibility for the batch documentation review process.
  • Lead and develop the team leaders in production towards a more LEAN and efficient way of working.
  • Work closely together with the QPs to ensure alignment on process/product investigations and follow up corrective actions.
  • To deliver efficient and timely review of Finished Product batch documentation for release and rejection activities.
  • To approve the decision making on daily queries online and play an active role in the resolution of these issues.
  • To perform process confirmations on the production lines with regards to batch documentation and manufacturing.
  • To approve process/product investigations (deviations) and follow up corrective actions identified.
  • To approve temporary change requests.
  • To approve process/product investigations (deviations) and follow up corrective actions identified.
  • To support Customer complaint investigations and response where applicable.
  • To provide Quality inspections system support including action close-outs.
  • To update SOP/WI’s as required for the Quality Release Department.
  • To participate in inspections by third parties, e.g. HPRA, FDA, customers, etc.,
  • To lead in the implementation of latest Quality legislation and guidance developments from Regulatory Authorities and Industry best practice.
  • To ensure audit readiness
  • To prepare daily handovers and report daily metrics on release.
  • To stay up-to-date with regulatory, qualification/validation, stability and other such key support programmes along with current legislation.

Qualifications:

  • A minimum of an honours degree in Chemistry, Biology, Engineering or equivalent third level degree qualification.
  • At least three years’ experience in a quality or manufacturing function within the pharmaceutical industry.
  • Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.

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