Joanna Anderson
Quality Assurance Manager @Ingenza Ltd
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WORK HISTORY
Quality Assurance Manager @Ingenza Ltd
Developed and implemented a Quality Management System in line with the requirements of ·(EU) 2017/1569 principles of and guidelines for good manufacturing practice for investigational medicinal products for human use; The Medicines for Human Use (Clinical Trials) Regulations 2004; SI 2004 No.1031; · 21CFR Part 211 Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs; and ISO 17025 General requirements for the competence of testing and calibration laboratories• Owned and managed updates to Quality Management System to include EU, UK and US Good Manufacturing Practice requirements.• Implemented electronic Quality Management System Software, which reduced Quality Team resource requirements. Recognised as subject matter expert.• Led internal audit programme and implemented of a system wide approach.
EDUCATION
The Open University
Post Graduate Diploma Modules, Computer Science
University of Aberdeen
Bsc, Pure Science
SKILLS
ABOUT JOANNA ANDERSON
Analytical Quality Systems Architect, with twenty years of experience in the field of medical devices and IVDs. Dynamic approach to Quality Management which allows for a practical application of regulations in line with the unique needs of individual businesses. Expertise in compliance and implementation of management systems. Skilled in auditing, and trained as Lead auditor through an IRCA approved training course. Keen to progress in QA and Regulatory Affairs
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