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Principal Quality Assurance Auditor

Principal Quality Assurance Auditor

  • plaats

    City of London, London

  • Sectoren:

    Life Sciences

  • soort baan:

    Blijvend

  • salaris:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • functie ref:

    PHARM-DEB_1564676798

  • gepubliceerd:

    12 maanden geleden

  • Vervaldatum:

    2019-08-31

  • Begin datum:

    ASAP

About the role:

  • The Principal Quality Assurance Auditor will report the Head of QA

  • Plan and set up the annual quality audit programme

  • Ensure the quality audit programme is followed and kept up to date

  • Conduct reporting and follow-up of quality system, computer system validation and service provider audits

  • Record the Audits results and reported and that corrective/preventative actions are documented

  •  Maintain the approved service provider list

  • Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA, Production of the annual trend analysis using QA metrics

  • Produce training documentation relating to quality and regulatory areas (if required). Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)


You should have expertise and experience:

  • GCP and CSV QA experience

  • Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies

  • Experience in the management of documents (Policies, SOPs etc.)

  • Expert knowledge of GCP and applicable regulations

  • Demonstrates leadership ability, communication, and facilitation skills

  • Be able to work on own initiative and able to function independently or as part of a team

  • Self-motivated

  • The role can be office or home-based.