Richmond Pharmacology’s continued growth is resulting in additional hires across all departments. We are hiring a QA Manager / Senior QA Auditor to assist in ensuring that Richmond Pharmacology is fully compliant with all regulations and can deliver high quality data for all of our clinical studies.
Title: QA Manager / Senior QA Auditor
Location: London Bridge, SE1
Hybrid: 80% Site Based - 20% WFH
To support QA Management in assuring quality throughout the Company. Promoting continual improvement processes to ensure all systems and procedures undertaken within Richmond Pharmacology Limited are compliant with ICH-GCP Guidelines, and other applicable regulatory requirements.
- To perform risk assessments of studies, systems and vendors, to prepare the audit schedule, in conjunction with QA Management.
- To organise and perform internal study and system audits, and vendor audits, as Lead Auditor, with another auditor, in accordance with the audit schedule agreed with QA Management, and reports are distributed, CAPAs evaluated, and audits closed. May involve 20% travel for vendor audits.
- To ensure CAPAs following internal study and system audits, and vendor audits are reviewed and closed.
- To maintain the audit schedule in the electronic Quality Management System, adapting priorities and documenting changes or updates as needed.
- To train other auditors, as applicable.
- To support QA management in assuring Richmond Pharmacology continues to meet applicable quality standards by communicating any observations or issues identified during day-to-day activities and provide consultation on CAPAs.
- To ensure non-conformances are reviewed, approved, and tracked until closure, using the electronic Quality Management System
- To ensure Quality Documents are reviewed and approved using the electronic Quality Management System and provide recommendations for process improvements.
- To support QA management with external audits or inspections, including corresponding with external auditors/inspectors, hosting, assisting with document requests and ensure CAPAs raised are reviewed, communicated and closed.
- To support QA management with preparation, review, formatting and presentation of slides for Quality Council meetings, Executive Board meetings, etc.
- To ensure organisation of the QA mailbox, such that emails are responded to, and organised accordingly and ensure organisation of QA shared area.
- To ensure the promotion and advancement of quality awareness and culture throughout Richmond Pharmacology, including performing QA trainings to all staff, and attending Project and ad-hoc meetings, as necessary.
- To train QA staff, as applicable, including distributing workload and monitoring task completion.
- To lead/collaborate/support QA initiatives/projects and to undertake any other reasonable duties that may be required from time to time as determined by QA Management.
If you would like to register your interest in the role, please submit a current copy of your CV via the link. You will also be asked for basic contact details and salary expectations.
We will endeavour to respond to every application, but current volumes of responses makes this impracticable. If you have not heard from us within 2 weeks of applying, please assume that you have been unsuccessful on this occasion.