Daniel Murphy
Gxp Quality Lead Responsible Person Uk Ie @Takeda
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WORK HISTORY
Gxp Quality Lead Responsible Person Uk Ie @Takeda
London, GB
Provide Quality leadership and technical support to the Ireland/UK MCO in order to ensure Takeda’s commercial products are distributed in compliance and ensure that all aspects of the GxP quality management system is implemented and maintained.Oversee quality-related licences and GDP activities for the local operation including pharmaceuticals, biologics, controlled drug activities, medical device, and plasma derived products. Responsible for ensuring the requirements of the Falsified medicines Directive are implemented as Market Authorisation Holder (MAH).RP and RPImports for the WDA in the UK for Takeda UK Ltd and RP in Ireland for Takeda Products Ireland Ltd.Responsible for ongoing integration of GxP processes and activities between Shire and Takeda for the UK/Ireland MCO post legal entity integration. Overseeing audit of the quality system, tracking and assisting in the closure of Internal and External Audit.Support Supply Chain activities to ensure continuity of supply and with Regulatory affairs on communications with the competent authorities.Contribute to develop and strengthen the MCO quality management systems and provide flexible support to business.Support Market Authorisation Holder activities such as Annual Product Quality Reviews, quality agreements with manufacturing facilities, communication with the competent authorities on recalls and market shortages.
EDUCATION
King's College London
Pharmacy, Pharmacy
ABOUT DANIEL MURPHY
Experienced quality assurance professional with a demonstrated history of working in the biotechnology industry, NHS and pharmacy homecare sectors. Extensive experience of GDP, GMP, quality assurance, aseptic pharmaceutical manufacturing and pharmacy homecare services. Continuously demonstrated the ability to implement changes and apply the knowledge and skills gained. A proven track record in dealing with Competent Authorities (HPRA & MHRA) and Pharmacy regulatory body (GPhC). Well rounded experience in developing and managing teams to meet internal and external customer expectations and deliver business targets.Skilled in Corrective and Preventive Action (CAPA), Quality Auditing, Change Control, SOP Authoring, and Document Management. Strong quality assurance professional with a Pharmacy degree from King\'s College, U. of London. Significant experience of being named as a Responsible Person on multiple licences.Currently named as Responsible Person and Responsible Person Imports for GDP on the Takeda UK Limited WDA and Responsible Person on the Takeda Products Ireland Limited WDA.Experienced user of a wide number of computerised systems including TrackWise, SAP, JDE, Navision, Veeva Vault, Saba, ISOtrain, Q-Pulse and general Microsoft programmes.
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