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Senior Quality Systems Manager
2 months ago
Looking for a Quality Systems Manager to join an Oncology focused Biotechnology company based in Oxford.
Provide coordination and management in the operation of the Quality Management System (QMS).
To ensure compliance to regulatory requirements, internal polices, Standard Operating Procedures and standards in the operation of the QMS.
To help ensure continuous improvement of the QMS.
At least 2 years’ experience in the operation of quality systems in a pharmaceutical quality related role. Experience of working within sterile pharmaceutical manufacturing and/or radiopharmaceutical manufacturing is desirable but not essential.
Administration and management of the eQMS, document management and learning management systems.
Oversight and coordination, to ensure the quality and timely management of:
Change controls / Deviations / CAPAs / Product Quality Reviews / Complaints / Self-inspection
Quality Risk Register
Preparation and management of finished product labelling and patient information leaflets
Plan and conduct internal audits and self-inspections
Provide training to staff on general or specific quality topics
Support the QA team in relation to quality investigations and initiatives
Prepare, manage and present materials for Quality Management Review
Contribute to continuous improvement activities and take ownership of continuous improvement tasks and projects.
Excellent IT skills for standard desk top packages (experience with Power BI desired but not essential)
Competent in problem solving, team building, planning and decision making
Associate Director, Quality Operations.
Flexible working available with the requirement to be onsite twice a week.
