Head of Quality Assurance
2 weeks ago
Pharma Partners are working with an established CRO based in London on their search for a Head of Quality Assurance - GCP.
The Role:
The main purpose of the Head of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements.
Main Responsibilities
- Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing 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.
- Conduct QA risk assessments for studies, systems and vendors to prepare the audit schedule, including coordinating and performing audits for studies, systems and vendors as Lead Auditor.
- Timely distribution of audit reports, evaluation of Corrective and Preventive Action and maintaining the audit schedule in the eQMS, adapting priorities and documenting changes or updates as needed.
- To ensure review of Computer System Validation (CSV) documents, and acting as QA approver, as necessary.
- Organising QA training for all staff - including distributing workload and monitoring task completion.
Qualifications and Experience:
- At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry.
- Strong knowledge of Quality Management Systems within the Pharmaceutical industry.
- Strong knowledge of ICH-GCP and GMP guidelines.
- Experience hosting, supporting and preparing MHRA inspections and auditing IT systems.
- Experience organising and performing internal and/or vendor audits.
- Experience working in a clinic in the early stage of their career.
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