Head of Quality Assurance

4 weeks ago

London, United Kingdom SRG Full time

Job Description

Here at SRG, we are proud to be partnering this established CRO based in London on their search for a Head of Quality Assurance.

The main purpose of the Head of Quality Assurance is to promote a quality culture of continual improvement to ensure all systems and procedures undertaken within the company are compliant with ICH-GCP Guidelines, and other applicable regulatory requirements.

Main duties and responsibilities

  • Ensure the company continues to meet applicable quality standards by communicating any observations or deviations identified during day-to-day activities, and support with their resolution.
  • Ensure Non-Conformances (NCs)/Incident Reports (IRs) are tracked, assessed, reviewed, and approved using the electronic Quality Management System (eQMS) ensuring actions proposed contribute to continual quality improvement.
  • Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS.
  • Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed, communicated, and tracked to closure in the eQMS.
  • Ensure the conduct of the QA risk assessment for studies, systems and vendors to prepare the audit schedule, including coordinating and performing audits for studies, systems and vendors as Lead Auditor, in accordance with the agreed audit schedule. Ensure timely distribution of audit reports, evaluation of Corrective and Preventive Actions (CAPAs), and closure. Maintain the audit schedule in the electronic Quality Management System (eQMS), adapting priorities and documenting changes or updates as needed.
  • Ensure the preparation and review, and to present slides at meetings, including Quality Council and/or Executive Board meetings.
  • To ensure review of Computer System Validation (CSV) documents, and acting as QA approver, as necessary.
  • Ensure organisation of the QA mailbox, to facilitate prompt email responses, and ensure organisation of the QA shared area.
  • Ensure the promotion of a high-quality culture throughout the company through organising QA training for all staff.
  • Manage and train other QA staff, including distributing workload and monitoring task completion.

As the ideal candidate you will have excellent knowledge of quality assurance and quality management systems within the pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines and as well working experience hosting sponsor audits and/or regulatory inspections. Experience organising and performing internal and/or vendor audits.

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