Description
A contract Quality Specialist is required to support an exciting Pharmaceutical Start Up project within Ireland.You will be involved in the approval /sign off of CSV/Automation related validation documents.
Skills/Experienced required:
*Ideally degree qualified
*Proven background in Quality approval gained working within a pharmaceutical/biopharmaceutical or medical device manufacturing organisation
*Proven background in reviewing and the approval of validation documentation at all stages of the validation lifecycle
*Strong understanding of regulatory bodies to include: FDA, MHRA and IMB
*Knowledge of ASTM E2500 risk approach
*Experience of PAI or Audits preferred
*Automation experience
*Knowledge with SCADA, EMS and BMS
This opportunity would suit an experienced Quality professional, who is looking to further develop their skills within a fast paced start-up environment