Company Profile

Q.A. Resources was established in 2003 and is based in Co. Tipperary, Ireland. We provide excellence in Quality Assurance Resources. Our highly educated personnel have extensive experience working within the API, Finished Pharmaceutical, Biotechnology, Medical Device and Healthcare industries. Our team has a combination of management and specialist experience in the areas of Quality Assurance, Quality Control and Validation.

As a result of our growing reputation for successful completion of projects, very hands-on approach and ability to resource varied needs using personnel with the appropriate skills we are providing an increasingly popular option to our customers both for ongoing and short-term projects. Our clients may avail of Q.A. Resources’ specialist support as part of their existing team or choose to select our team to completely project manage a solution to meet their requirements.

Projects include:

• Prepare, review, approve all SOPs and train personnel for a new GMP compliant product development facility
• Prepare a Quality Manual and all supporting procedures for a new medical device manufacturing facility
• Site Preparation Project for Regulatory Inspection
• Contract Qualified Person support
• Management of Vendor Assurance Programme, including development of GMP compliant SOPs, completing the vendor audit schedule and monitoring vendor performance
• Conduct Internal Audit of Manufacturing and Training Departments & site Quality Systems
• Review and Update of all SOPs for a manufacturing site
• Preparation of Product Quality Reviews
• Devise a Training Manual for a new item of manufacturing equipment
• Provide a Quality Assurance Resource during start-up of a biotech manufacturing facility and a contract pharmaceutical packaging facility
• Devise Plan for Water and Environmental Monitoring Programmes and write relevant procedures
• Provide Quality support for a new device launch from development to market
• Review and Approval of Out of Specification Investigation Reports
• Provide a Resource to Conduct Investigations and Prepare Reports to address Non-Compliances using a client’s Deviation Handling system
• Batch Manufacturing Record documentation review
• Preparation and review of Validation documentation
• Co-Ordination of Process Validation Project
• Upgrade of batch review and release systems and QC procedures for medical device QC unit

Our Clients include:

• Abbott Vascular, Clonmel
• ALZA Ireland Limited, Cashel
• Boston Scientific Ireland Limited, Galway
• Cordin Cork Limited (formerly Cambrex)
• Fournier Laboratories, Cork
• Genzyme Ireland, Waterford
• Millipore, Cork
• Schwarz Pharma Ltd, Shannon (part of UCB Group)
• Stiefel Laboratories, Sligo
• Stryker Biomaterials, Limerick
• Stryker Biotech, Limerick
• Stryker Orthopaedics, Cork & Limerick
• Taro Pharmaceuticals, Roscrea
• Teva Pharmaceuticals, Waterford (formerly IVAX)
• USCI, Ballinasloe
• Vistakon Ireland, Limerick

   

Contact us at enquiries@qaresources.com for further information