Hobson Prior are recruiting for a Senior QA Associate to join a clinical-stage gene therapy organisation who are determined to develop treatments for people who are living with serious illnesses.
Job Responsibilities :
Manage the Quality Management System.
Generation, Review and approval of relevant GMP documentation.
Maintain QA KPI metrics.
Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
Co-operate with Operational areas, proactively manage the day to day QA Operations.
Review Batch documentation and manage QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-
Manage and support QA team Facility walk rounds and QA support for all operational areas.
Deliver direct quality team support during customer and regulatory audits.
Complete internal audits and inspections and audit write up.
Quality Systems : Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA’s and Change Controls.
Provide QA review for the eQMS system.
Create and review Risk reporting and Mitigation.
Proactively initiate and support continuous improvement of the Quality Management System.
Deliver compliance training to operational areas.
Key Skills :
Good organisational and time management skills.
Capable to prioritise workload can work within agreed timescales.
A meticulous eye to detail.
Strong verbal and written communication skills.
Proficient in Microsoft Office and experience in database use and eQMS systems.
Prior experience of working within a GMP manufacturing environment.
Understanding controlled processes.
Knowledge of GCP and GMP with regards to QMS activities
Experience in Competent authority, Regulatory body inspections and audits.
Experience working in a GxP environment including a minimum 5 years’ experience in Compliance and Quality Assurance.
IT literate, experience managing and operating an electronic QMS.
Apply now :
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.
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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.