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Senior / Principal QA Advisor

Oracle

Senior / Principal QA Advisor

Salary Not Specified

Oracle, Fordham, Cambridgeshire

  • Full time
  • Permanent
  • Onsite working

Posted 3 weeks ago, 25 Aug | Get your application in now before you miss out!

Closing date: Closing date not specified

job Ref: b379a42dfaf544dcb940fe8de4241ee4

Full Job Description

  • Perform study, process and facility audits as required according to the audit program and study deadlines.

  • Maintain a strong knowledge of the current regulations and guidance.

  • Provide guidance and advice on regulatory requirements.

  • Support Quality Management System(s).

  • Support external inspections, customer audits & enquiries as required.

  • Support the delivery of training modules.

  • Actively seek and drive process improvements and continuous Improvement wherever possible.

  • Support the internal self-inspection programme.

  • Support deviation investigations, OOS, Change Control and CAPA to completion.

  • Lead the planning, coordination and execution of global supplier programme, including;


  • Maintain Resolian’s Global Supplier Database

  • Action new supplier requests

  • Assess new suppliers according to Resolian’s risk-based criteria

  • Perform periodic supplier assessments as per Resolian’s schedule

  • Monitor and report metrics on supplier sustainability

  • Lead periodic meetings with high risk suppliers

  • Lead the reporting of complaints and other supplier issues.


  • Participate in external sponsor audits on matters related to supplier qualification and feedback comments into process improvements.

  • Build effective relationships with suppliers and act as a point of focus for external communications.

  • Liaise with clients and internal stakeholders in the preparation and execution of quality agreements.

  • Maintain regulatory agency registrations (FDA, EMA, DUNS, etc) as required.

  • Act as a contact point for the client quality agreements and regulatory agency registrations, ensuring documentation is accurate and current.

    Strong knowledge and understanding of working within a GxP or ISO regulated environment and their application.

  • Demonstrable audit skills that can be practicably applied to auditing activities as a sole auditor or as part of a team.

  • Experience of establishing audit scope and developing relevant audit schedules and checklists.

  • An understanding of the function of the QMS and actively supporting QMS systems such as Deviations, OOS, Change Control and CAPA.

  • Able to demonstrate strong customer (internal and external), supplier and regulator interaction skills.

  • Experience working within the pharmaceutical industry is preferable.

  • Minimum level of BSc in scientific field or recognised auditor certification, or equivalent industry experience


    • Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

    We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

    If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.