Senior Quality Assurance Auditor

1 month ago

London, Greater London, United Kingdom newscientist - Jobboard Full time

About the Role

We are seeking an experienced Quality Assurance Auditor to join our team at hVIVO. As a Quality Assurance Auditor, you will be responsible for ensuring that our company is in compliance with relevant SOPs, regulations, and internationally recognized guidelines. This includes conducting audits of all systems, processes, facilities, documents, and studies within hVIVO and of suppliers and subcontractors to hVIVO.

The successful candidate will have a sound knowledge of GCP and GCP for laboratories regulatory standards, as well as experience in quality assurance auditing and quality system experience. They will also have excellent communication skills and a pragmatic and diplomatic approach to problem-solving.

Main Responsibilities

The main responsibilities of this role are:

  1. Plan and conduct assigned audits of hVIVO processes, systems, facilities, studies, and documents to verify compliance and determine the effectiveness of the company's quality systems and procedures;
  2. Plan and conduct assigned audits of low to medium risk suppliers and subcontractors to hVIVO by conducting remote audits;
  3. Plan, conduct and follow up audits of high-risk suppliers performed at the suppliers' on-site premises;
  4. Follow up and close out all assigned audits including agreement of appropriateness of corrective actions to audit findings with relevant hVIVO staff;
  5. Assess compliance with the hVIVO Quality Management System (QMS) and ensure appropriate actions are agreed and effectively followed up;
  6. Maintain an up-to-date knowledge of the current regulations, guidelines, and hVIVO SOPs.

Internal Audits

  1. Plan for audit by reviewing previous audit reports and relevant legislation and guidance;
  2. Produce audit plan where relevant to detail scope of the audit;
  3. Conduct allocated process, system, facility, study, document, and data audits by reviewing relevant documentation, observing relevant procedures, and tours;
  4. Assess compliance of the process, system, facility, study, or document and categorize audit findings appropriately;
  5. Conduct audit close-out meetings to present findings to relevant hVIVO staff;
  6. Produce audit report detailing audit summary, scope, and findings and present for peer review;
  7. Conduct peer reviews of colleagues' audit reports to ensure accuracy and appropriateness of findings and classification of findings;
  8. Follow up on audit responses not received within assigned timeframe;
  9. Assess audit responses for appropriateness of corrective and preventive actions and advise auditee on appropriate responses until agreement is reached;
  10. Conduct QA review of SOPs and associated Master Forms as part of review and approval system within QuMas;
  11. 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

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

Hosting External Audits

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

Compliance with Industry and Company Procedures and Training

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

Skills & Experiences

  1. Demonstrated experience in quality assurance auditing and quality system experience;
  2. Excellent knowledge of GCP and GCP for laboratories regulatory standards;
  3. GCP or GCP for laboratories experience in pharmaceutical or CRO or NHS/Academia;
  4. Proven knowledge of drug development processes;
  5. Working knowledge of GLP and GMP standards;
  6. Proven communication skills with the ability to communicate with all levels within hVIVO;
  7. A pragmatic and diplomatic approach to problem-solving;
  8. Excellent attention to detail;
  9. Degree in Science or equivalent desirable.

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