Senior Quality Assurance Auditor

6 days ago

London, Greater London, United Kingdom hVIVO Full time

About the Role

hVIVO is seeking a highly skilled Senior Quality Assurance Auditor to join our team. As a Senior Quality Assurance Auditor, you will play a critical role in ensuring that our company is in compliance with relevant SOPs, regulations, and internationally recognized guidelines.

Main Responsibilities

  • Plan and conduct audits of hVIVO processes, systems, facilities, studies, and documents to verify compliance and determine the effectiveness of our quality systems and procedures.
  • Conduct audits of low to medium risk suppliers and subcontractors through remote audits.
  • Plan, conduct, and follow up on-site audits of high-risk suppliers.
  • Follow up and close out all assigned audits, including agreement of appropriateness of corrective actions to audit findings with relevant hVIVO staff.
  • Assess compliance with the hVIVO Quality Management System (QMS) and ensure appropriate actions are agreed and effectively followed up.
  • Maintain an up-to-date knowledge of current regulations, guidelines, and hVIVO SOPs.

Internal Audits

  • Plan for audit by reviewing previous audit reports and relevant legislation and guidance.
  • Produce audit plans where relevant to detail the scope of the audit.
  • Conduct allocated process, system, facility, study, document, and data audits by reviewing relevant documentation, observing relevant procedures, and tours.
  • Assess compliance of the process, system, facility, study, or document and categorize audit findings appropriately.
  • Conduct audit close-out meetings to present findings to relevant hVIVO staff.
  • Produce audit reports detailing audit summaries, scopes, and findings and present for peer review.
  • Conduct peer reviews of colleague's audit reports to ensure accuracy and appropriateness of findings and classification of findings.
  • Follow up on audit responses not received within assigned timeframes.
  • Assess audit responses for appropriateness of corrective and preventive actions and advise auditees on appropriate responses until agreement is reached.
  • Conduct QA reviews of SOPs and associated Master Forms as part of the review and approval system within QuMas.
  • Plan, conduct, and follow up audits across all business areas within hVIVO and all audit types and document types (laboratories, clinical, data management, computer system validation).

Audits of Suppliers and Subcontractors

  • Plan, conduct, and follow up allocated remote (questionnaire and due diligence) audits.
  • Compile relevant questions to assess compliance of services being provided.
  • Assess information provided or sourced to provide decisions on suitability of suppliers or subcontractors to provide services to hVIVO and add to QA-approved suppliers list.
  • Plan, conduct, and follow up onsite audits in line with the supplier audit plan.
  • Act as Lead Auditor to plan, conduct, and follow up on-site audits of suppliers and subcontractors in line with the supplier audit plan.
  • Liaise with relevant hVIVO staff requesting use of the supplier or subcontractor to ascertain scope of the audit required.

Hosting External Audits

  • Assist with external Sponsor audits and regulatory inspections.
  • Manage the back room for Sponsor and regulatory audits.
  • Liaise with relevant hVIVO staff to provide documents requested as part of the audit/inspection.
  • Assist with compiling responses to audit reports from Sponsors and regulatory authorities.

Compliance with Industry and Company Procedures and Training

  • Have a sound knowledge of industry regulations, guidelines, and standards.
  • Have a sound knowledge of business operational procedures and company documents and procedures.
  • Where required, attend external training courses and feedback information to QA.
  • Be a member of RQA and keep up to date with current industry practices, regulatory requirements, and industry news.
  • Train and assess competency of Trainee QA Auditors and QA Auditors.

Requirements

  • Demonstrated experience in auditing suppliers, vendors, clinical sites, and laboratories.
  • Excellent knowledge of GCP and GCP for laboratories regulatory standards.
  • Working knowledge of GLP and GMP standards.
  • Proven communication skills with the ability to communicate with all levels within hVIVO.
  • A pragmatic and diplomatic approach to problem-solving.
  • Excellent attention to detail.
  • GCP or GCP for laboratories experience in pharmaceutical or CRO.
  • Quality assurance auditing and quality system experience.

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