QA Manager (6 month FTC)
- Experience Level
Hobson Prior are looking for a QA Manager to join a pharmaceutical organisation who provide support to the pharmaceutical and biotech industry in the development and commercialisation of products globally. This position is to be home-based.
- Co-operates with the Business Process Owners/Subject Matter Experts to determine processes.
- Authors the QMS document.
- You will ensure that the QMS document fulfils the necessary regulatory requirements.
- Seeks review and input on draft QMS document from the Business Process Owners/Subject Matter Experts in order to produce the final draft ready for QA Review.
- Back-up role for SOP Management.
- Back-up role for Training Records Management
- Lead role for hosting of audits as assigned by the QA Head of Function.
- Back-up role for audit responses, deviation and CAPA management.
- Deputises for Head of QA for managing audits and inspections, when assigned.
- Resource Management: QA Consultants involved in SOPs and Training Records.
- GXP Specialisms: GCP and GVP.
- Promote the Quality Assurance function internally and drive continuous improvement of the Quality Management System.
- Support internal functions as an internal customer service.
- Maintain an awareness of the Quality Management System; knowledge of applicable GXP related SOPs/WIs and legislation/guidance.
- Education to graduate level in a science discipline, nursing or equivalent, or possession of substantial relevant experience in a Clinical Research/PVG or QA environment.
- Clinical Research / PVG / QA qualification or equivalent hands on experience.
- Prior experience in authoring and developing SOPs and related documents.
- Prior QA related role preferred but not mandatory.
- Clinical Operations experience with sound knowledge of GCP and applicable legislation.
- GVP, GDP Or GMP experience would be preferred.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.