Catherine O’Brien – Quality Systems Manager and Quality Auditor

Quality Systems Manager and Quality Auditor Catherine O’Brien

Prior to establishing Q.A. Resources in January 2002, Catherine worked as a Quality Systems Manager, Product Release Manager, QP, Microbiologist and Validation Co-ordinator within the pharmaceutical and cosmetics industries. In addition to managing Q.A. Resources, she continues to work in various varied roles on a contract basis within the pharma, medical device and API sectors.

Catherine has a BSC (Hons) in Microbiology, a Higher Diploma in Education and a Diploma in Pharmaceutical Manufacturing Technology. She is an experienced Qualified Person and also a Lead Assessor with extensive experience as a quality auditor.

With a professional and positive approach, Catherine’s contracts currently include contract QP in oral dose, quality auditing, implementation of quality systems in start-up medical device facility, to name but a few. She has devised and implemented new and revised quality systems, training site personnel. She gives excellent insight to quality issues, always providing practical solutions.

Skills and Experience:

• Quality Systems management
• Qualified Person
• Qualified Lead Assessor/GMP Audits
• Regulatory Inspection preparation and support
• Trainer (Train the Trainer and Higher Diploma in Education)
• Microbiology support
• Japanese Cultural Studies