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QA Auditor (GCP and CSV required)

QA Auditor (GCP and CSV required)

  • Location

    Norfolk, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    bens

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    74842-PHARM-DEB_1565257005

  • Published:

    2 months ago

  • Expiry date:

    2019-09-07

  • Start date:

    ASAP

  • Consultant:

    #

We have an exciting opportunity to join a Quality team reporting to the Head of QA, you will provide day-to-day support to the quality assurance function. You will be responsible for assisting in the management of the Quality Assurance program component within the company and will work with our other departments to assure regulatory compliance and consistency with the policies and procedures.
We are proudly partnering with one of the largest specialist data-focused contract research companies in Europe supporting human clinical trials developing new life-saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, our client is a market leader in the healthcare arena. Supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services.


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

  • Experienced 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.