Peter Rose Email & Phone Number

Herefordshire, England, United Kingdom

Quality, Regulatory and microbiological expertise for Medical Devices and IVDs across the UK and Europewww.prqr.co.uk

Nottingham, United Kingdom

High Edge Consulting was acquired by Maetrics LLC in September 2013. High Edge Consulting, has now been renamed Maetrics Ltd, and continues to be based at BioCity Nottingham serving the same client base. Maetrics is a full service life sciences consulting firm. Founded in 1984, Maetrics has evolved to become a global force supporting a significant number of pharmaceutical, biopharmaceutical and medical device firms with their most critical enterprise compliance, performance improvement, risk management, information technology and organizational change management initiatives.Our company is exclusively focused on the life science industry, enabling us to provide superior insights to our clients. Our unique business acumen and delivery model has been rewarded by repeated engagements with our client base year after year.Today, with offices throughout the United States and Europe, Maetrics is an acclaimed leader in the life science consulting field. Compliance Agility + Global AcumenDiscover why Maetrics will be the “plus” for your business. www.maetrics.com

Founding director of High Edge Consulting Ltd. Responsibilities include all aspects from initial customer contact through to delivery of consultancy services covering the 7 key services, customer liaison and customer care, marketing activities and business strategy planning. The 7 key services are: Quality Systems; Regulatory Affairs; Contamination Control; Microbiology; Sterilisation; Validation and Training.

Responsible for the quality management system at HQ and three service sites, 2 Site QA Coordinators, routine quality system requirements, responding to customer audits, internal audits, supplier assessments and critical supplier audits, cleanroom validation and acting as the Company Microbiologist.

Responsible for the quality function, managing the laboratory and 2 staff. Quality Management System responsibilities included: planning and organising internal audits; writing, actioning, trending key indicators; procedure development and document control; preparing, chairing management review; new vendor assessment, audit, and performance review; planning, writing validation protocols; receiving, responding to regulatory body and customer audits; training site personnel in GMP and basic microbiology; deputising for the General Manager. The role of QA Microbiologist was as the contamination control and quality consultant for customers with cleanrooms. Services included advice, interpretation and implementation of ISO-11137, EN 552, ISO 11135, EN 550, ISO 9000 series, EN 46000 series, ISO 14644 series, Federal Standard 209E; cleanroom particle monitoring; dose audit; dose setting; facility audit; operator training; microbiological testing.

Responsible for managing the laboratory function including 5 technicians. Laboratory services included: biological indicator testing; LAL endotoxin by kinetic chromogenic method; residual EtO determination by gas chromatography; bioburden; environmental monitoring. Other responsibilities included maintenance of all laboratory procedures in accordance with the quality system; staff training, both laboratory personnel and cross training with other departments; laboratory recruitment; supplier negotiations; final product release; receiving and responding to customer audits.