Quality Assurance Auditor

Recruiter
Venn Life Sciences part of Open Orphan Plc
Location
The City, UK
Salary
Competitive salary
Posted
04 May 2021
Closes
17 May 2021
Ref
2125099922
Job role
Audit
Conduct audits of systems, processes, facilities, documents and studies within hVIVO in order to deliver the audit programme as required by GCP. Ensure that hVIVO are in compliance with the relevant SOPs, regulations and internationally recognised guidelines (including Statutory Instrument 2004 No. 1031 and its amendments, ICH GCP and GCP for laboratories).

  • Plan and conduct assigned audits of hVIVO processes, systems, facilities, studies and documents including protocols, reports, computer system validation documents in line with the annual audit programme and appropriate study audit plans to verify compliance and determine the effectiveness of the company's quality systems and procedures with agreed timescales;
  • Plan and conduct assigned remote audits of low and medium risk suppliers and subcontractors to hVIVO.
  • Work cross functionally to follow up and close out 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 the current regulations, guidelines and hVIVO SOPs.


Internal audits
  • Contact relevant hVIVO staff to arrange allocated audit
  • Plan for audit by review of previous audit reports and relevant legislation and guidance
  • Produce audit plan where relevant to detail scope of the audit
  • Conduct allocated process, system, facility, study, document and data audits by review of relevant documentation, observing relevant procedures and tours of facilities.
  • Assess compliance of the process, system, facility. Study or document and categorise audit findings appropriately
  • Conduct audit close out meetings to present findings to relevant hVIVO staff
  • Produce audit report detailing audit summary, scope and findings and present for peer review.
  • Follow up if audit response not received within assigned timeframe
  • Assess audit responses for appropriateness of corrective and preventive actions and advise auditee on appropriate responses until agreement is reached
  • Conduct QA review of SOPs and associated Master Forms as part of review and approval system within QuMas


Audits of Suppliers and Subcontractors
  • Plan, conduct and follow up allocated remote (questionnaire and due diligence) audits
  • Compile relevant questions to assess compliance of service being provided.
  • Assess information provided or sourced to provide decision on suitability of supplier or subcontractor to provide services to hVIVO and add to QA approved suppliers list.
  • Under supervision plan, conduct and follow up onsite audits in line with the supplier audit plan.


Hosting external audits
  • Assist in running the back room for Sponsor and regulatory audits.
  • Liaise with relevant hVIVO staff in order to provide documents requested as part of the audit/inspection


Compliance with Industry and Company Procedures
  • Have a sound knowledge of Industry regulations, guidelines and standards;
  • Have a sound knowledge of business operational procedures and company documents and procedures;
  • Escalate any issues to Line Manager;
  • Where required attend external training courses and feedback information to QA;
  • Be a member/associate member of RQA and keep up to date with current industry practices, regulatory requirements and industry news


This is a non-exhaustive list

Person Specification

Essential
  • Degree in Science or equivalent
  • Proven knowledge of drug development processes
  • Excellent knowledge of GCP and GCP for laboratories regulatory standards
  • Proven communication skills with the ability to communicate with all levels within RVL
  • A pragmatic and diplomatic approach to problem solving
  • Excellent attention to detail
  • Innovative


Desirable
  • Further qualification in Science or Quality
  • Experience in supporting regulatory inspections and client audits
  • Working knowledge of GLP and GMP standards

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