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  • Location: Nottingham, Nottingham, England
  • Salary: Very generous salary and benefits package
  • Job Type:Permanent

Posted 18 days ago

  • Sector: Quality, IRT & Informatics
  • Contact: Steve Twinley
  • Contact Email: steve.twinley@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Start Date: 2021-07-13
  • Job Ref: V-46946
Do you have strong experience in CSV auditing, gained in a regulated Pharmaceutical, Clinical or CTS setting? Do you have RTSM / IRT experience, gained in either sponsor or vendor environments? We are looking for a skilled Auditor who has expertise in planning, conducting and managing audits and is able to drawn upon a range of skills to help the development of a leading RTSM software provider.
 
This is a permanent role for a Senior Quality Auditor, with an excellent salary and benefits (to discuss on application). Given that you can work largely remotely, you can be based in either East Coast US, UK, or Mainland Europe, though you must be willing to travel if required. If you are based in the UK, it will be helpful if you live within a short distance of Nottingham, but this is not essential.
 
You will join an award-winning global leader in randomization and trial supply management (RTSM) for the global life sciences industry. They have built a culture that embraces innovation and the spirit of experimentation in order to fully explore and harness the possibilities of their technology, which is fully customisable to meet the needs of complex clinical trials.
 
As Senior Quality Auditor, your role will include:
 
  • Planning, conducting and reporting of internal audits assigned per the quarterly audit schedule or requested by Quality Audit Lead or Quality Management.
  • Conducting internal audits of all corporate products and areas related to the company’s product and services offerings, including Product Development life cycle, Study Development life cycle, Training, Client Studies, Data audits, product releases, change control.
  • Providing guidance for issue resolution as applicable, and work with Computer Systems Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.
  • Relaying feedback to client partners following audits.
  • Auditing to regulations, procedures, and industry best practices.
  • Preparing audit reports and certificates.
  • Providing mentoring to junior auditors.
  • Participating in continuous improvement of procedures and overall quality system.
  • Monitoring and analyzing results of internal audits for trends. Working with the Quality Audit Lead for audit reporting and escalations to Quality Management.
  • Assisting in hosting client audits and participating in all regulatory inspections.
 
Required Experience
 
  • The successful candidate must possess a bachelor’s degree in a life sciences or information technology field, or have equivalent auditing experience.
  • Significant experience as an auditor in a regulated environment, including auditing Computer Systems Validation (CSV). Skills in audit planning, audit conduct, and audit management are essential.
  • RTSM (Randomization and Trial Supply Management) / IRT / IVRS / IXRS software experience is desired but not essential.
  • Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification would be desired but is not essential.