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Clinical Quality Assurance Auditor

Central London   •  Negotiable  •  Permanent, Full time

Main Responsibilities

  • Plan and conduct assigned audits of company processes, systems, facilities, studies and documents including protocols, reports, and computer system validation documentsin line with the annual audit programme and appropriate study audit plans to verify compliance and determine the effectiveness of the companys quality systems and procedures with agreed timescales;
  • Plan and conduct assigned audits of low to medium risk suppliers and subcontractors to company by conduct of remote audits;
  • Plan, conduct and follow up of audits of high risk suppliers performed at the suppliers on site premises;
  • Follow up and close out all assigned audits including agreement of appropriateness of corrective actions to audit findings with relevant company staff;
  • Assess compliance with the company 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 company SOPs.

Internal Audits

  • 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;
  • 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 company staff;
  • Produce audit report detailing audit summary, scope and findings and present for peer review;
  • Conduct peer reviews of colleagues audit reports to ensure accuracy and appropriateness of findings and classification of findings;
  • Follow up of 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;
  • Plan, conduct and follow up audits across all business areas within company 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 service being provided;
  • Assess information provided or sourced to provide decision on suitability of supplier or subcontractor to provide services to company 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 company 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 company staff in order 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.

Skills & Experiences

  • Degree in Science or equivalent
  • Proven knowledge of drug development processes
  • 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 company
  • A pragmatic anddiplomatic 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

  • Agency: Cpl Life Sciences
  • Contact: Sheldon Grant
  • Reference: JO-2109-476939
  • Updated: 17th November 2021
  • Expires: 15th December 2021

Cpl Life Sciences

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