CAREERS

Computer Systems Auditor

Location: Guildford, UK

PrimeVigilance is continuing to expand and is looking for a Computer Systems Auditor to join our dynamic and rapidly growing organization.

This role effectively is to support Associate Director Computer Systems QA in the conduct of internal and external (third-party) audits of Computerised Systems to provide independent and objective fact-based opinions and to assure compliance with applicable PrimeVigilance´s and/or Client´s procedures and local and global regulatory requirements as well as contractual agreements..


Key Accountabilities
  • Conduct Computer Systems Validation (CSV) audits initiated by PrimeVigilance, according to the agreed Audit Programme including effective management of pre-audit activities as instructed by Line Management;
  • Audit types include:o Audits of Primevigilance’s Partners and Vendors/Service Providers;
    o Internal Audits of Business Computer Systems and IT Processes;
    o Audits of Third Parties on behalf of Clients on Computer Systems.
  • Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
  • Generate and monitor audit metrics;
  • Audit – internal
    o Effective management of pre-audit activities: Communication with Auditee, preparation of Quality plan, Audit plan, Audit checklist, etc. in agreed formats and timelines;
    o Conduct Computer Systems audits initiated by PrimeVigilance, according to the agreed Audit Programme and in line with agreed Audit plan and Quality plan;
    o Document audit findings and recommendations and identify process improvement initiatives and document them in an Audit report in agreed formats and timelines;
    o Plan, create and maintain Corrective and Preventative Action Plans if needed, on an assigned audit basis;
    o Generate and monitor audit metrics and performance evaluation;
    o Act as Lead Auditor on an assigned audit basis: Support Audit Teams as required, providing CSV support ensuring that audits comply with applicable Primevigilance and/or client´s procedures and local and global regulatory requirements as well as contractual agreements.
  • Audit by client (including pre-qualification)
    o Acts as key contact and acts as the host for client CSV audits;
    o Ensures audit observations are shared and actions taken upon receipt of audit report;
    o Reviews responses prior to submitting to clients.
  • Inspections (client / company)
    o Assists in supporting (where required) inspections of Primevigilance on behalf of the client for CSV related subjects.
  • Audit as a service
    o Conduct CSV Audits of Third Parties on behalf of Clients in line with agreed Audit plan and Client´s specification;
    o Writes/reviews all Third Party audit reports before distribution to client.
  • Pre-qualification CSV audits of potential Primevigilance vendors
    o Performs due-diligence review or pre-qualification PV audits of potential vendors partners, consultants and acquisitions;
    o Documents and communicates result of review/audit, with recommendations if required.
  • CAPA
    o Reviews and approves all final CAPA plans from internal audits and client audits within timelines mandated by PrimeVigilance procedures.
  • Metrics, Analytics and Trending
    o Assists in trending audit and CAPA data in order to identify actionable trends and risk areas.
  • PV consultancy
    o Acts as subject matter expert on CSV to the company, as required;
    o Consults with PV functions to ensure they are CSV audit and inspect ready.
  • Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of Primevigilance and/or Client as per operational needs;
  • Keep up-to-date about the relevant regulations, legislation of CSV subjects for Pharmacovigilance, participate in relevant seminars and trainings;
  • Participate in workshops or trainings organised by Primevigilance and create/develop and present training to Primevigilance staff on applicable regulatory requirements.

Qualifications and Skills
  • A minimum of 3 years applicable pharmaceutical and/or biotech pharmacovigilance experience with a understanding of CSV-related Quality Management and Assurance
  • GxP Knowledge: In-depth knowledge of the applicable GxP regulations eg EU and FDA regulations particularly EU GVP
  • Experience in performing internal/external or supplier audits
  • Analytical, written and oral communication skills
  • Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines
  • Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving
  • Strong team player
  • Good / Strong English language skills (written and spoken) additional languages a plus, but not required

Our Offer
  • Temporary contract for maternity leave cover
  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast growing healthcare company.

If you would like to be considered for this opportunity, please send your application via email to careers@primevigilance.com enclosing your English CV and Cover Letter.

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Thank you for your application. Unfortunately, because of the volume of applications we receive, we are not able to give status updates, but if you are invited for an interview, we will contact you directly.

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