Lead QP ( Qualified Person) Ref: OLPGC A highly experienced Medical Devices and In Vitro Diagnostics manufacturing and quality / regulatory professional having implemented Food and Drug • Qualified Person. Experience of solid-dose products, parenterals, implants, devices, creams, biotechnology products, sterile imaging materials, vaccines, clinical trial materials, medicinal gasses. Management Manager for an analytical function with a staff of 40 Selection of Consultancy/project work Mentoring of Qualified Persons Development of cross-site disposition system for clinical trail materials Set up of company product stability programme Auditing of contract laboratories & manufacturers Pre-regulatory inspection and routine compliance audits Preparation and submission of licence variations Co-ordination of recalls, liaison with IMB, preparation of final reports Director (VP Level) Quality Management Consultant Ref: OLPDRMM BSc PhD Chemistry MBA Most recent assignment involved Dirctor level appointment with a top 10 global pharmaceutical corporation enagaged in wide range of dosage forms. Successful track record in managing drug substance, drug product, distribution and market sectors, and building sustainable operational performance in FDA and EU environments. Has be responsible for managing multi sites across EMEA regions including overseeing wide variety of contract/third party manufacturers. Six Sigma Blackbelt Process Improvement Consultant Ref: OLPPBNI Over 25 years experience in precision engineering and automative manufacturing sector working in Quality Engineering,Quality Management and in Project Leadership roles focusing on process and quality improvement through lean manufacturing and six sigma manufacturing systems. Has recently lead a major muliti million euro Corporate Project focusing on supplier development  accross UK and European production facilities.  Senior Management Quality Consultant Ref: OLPJD BSc PhD Chemistry MBA This Candidate has 20 years were in pharmaceutical operations. He has worked with major companies and managed many pharmaceutical projects internationally, and has specialist up-to date expertise in pharmaceutical operations, quality assurance and control management. He most recent project involved working as EMEA Head of Quality for Quality. Prior to this assignment he was involved for a number of years woking with acquestive and global generics manufacturer focusing on upgrading quality standards to EU/FDA Regulatory Standards in acquired companies predimonately located in Eastern Europe. He also worked for many other companies including Wyeth Biopharma at their sites in the US and Ireland, for Taro, Norgine in Wales, CSL Group in Australia and Switzerland, and Leo Laboratories in Dublin. He fulfils the EU requirements to act as a QP. Quality & Training Consultant Ref: OLPEF Chartered Chemist (C.Chem. MRSC) and has over 27 years experience working in highly regulated Chemical and Pharmaceutical environments in management roles spanning quality assurance, production and human resources. He has been on the Qualified Persons Register ('QP' under the European Pharmaceutical Directive) from 1988. Since 1997, as an independent operator, he has provided training (design and delivery), regulatory affairs consultancy and interim management, and over this time he has developed a solid reputation as an excellent consultant. Through his training programmes he has typically related to quality assurance, compliance, regulatory management and senior technical staff and he has also delivered Health and Safety training, and has an N.E.B.O.S.H. certificate (National Examination Board for Occupational Safety and Health).Quality Consultant Ref OLPAK Has worked in the Pharmaceutical and Medical Device Industry since 1989. Initially worked in the as a Senior Laboratory Technician then worked for Biopharmaceutical Manufacturing Company as a Senior Quality Control Analyst in their Quality Laboratories. She then joined Solid Dosage Manufacturing Company as a Compliance Executive.  They worked with the Irish Regulatoror in the area of  Registration and Compliance.   For the past six years they have worked as a Quality & Training Consultant specialising in the provision of cGxP training, compliance auditing and consultancy, to the Life Science Industry in Ireland. Quality Consultant Ref OLPAK Over 20 years experience in Life Science Industry initially in Quality Control Laboratories.They then moved into Compliance intially in Industry and later working for the Irish Medicines Board (IMB) with responsibility for Registration and Compliance. For the last 7 years they have worked as a Quality & Training Consultant specialising in the provision of cGxP training, compliance auditing and consultancy, to the Life Science Industry in Ireland. Below is selection of recent assignment: Involved in Compliance Auditing relevant to ISO, FDA & EU regulations on behalf of Wholesale Distributors, Active Pharmaceutical Ingredient companies (API), Pharmaceutical and Medical Devices companies, ensuring the companies and their suppliers meet regulatory requirements. Prepared and managed project plan, co-ordinating internal departments to resource the development of job curricula, individual training plans to ensure continued staff development, competent assessments and documentation systems to support program. In addition, developed and delivered customized training program to all staff. Assisted a UK Client Company to streamline the Pharmacovigilace reporting system in Ireland. This involved managing the project from development to rolling out the system within Ireland incorporating the training of all personnel from sales representatives to senior management. System Implementation and Management: Implemented quality systems for clients ranging from wholesalers to biopharmaceutical companies. Iintroduced a deviation and corrective action management system in one company which saw backlog reduced by over 50% within one month. Training: Worked with clients to develop and present customized cGxP training programs to ensure companies meet their regulatory requirements. Quality Medical Devices Consultant Ref: OLPJHM Administration Part 820, ISO 9001 & ISO 13485 Quality Management Systems Worldwide and developed and presented Quality Management System training programmes on Medical Devices and In Vitro Diagnostics at all levels within multi national organisations. Has demonstrated commitment and energy by operating as a self employed Management Consultant for the past eighteen years, travelling extensively to assist Medical Device clients with their manufacturing and Quality implementation and improvement programmes culminating in registration to international quality standards. In addition, has acted as a senior representative for several well-known Quality Certification Bodies (Notified Bodies) implementing training and auditing assignments Worldwide for all the Medical Devices Directives and CE marking as well as ISO 9001 & ISO 13485. Prior to this had occupied several management posts in both US and European based Device corporations developing and supporting In Vitro Diagnostics and Medical Devices in development, manufacturing, servicing and quality roles. Has also undertaken further studies resulting in an MSc in Total Quality Management. Operational Quality Manager Medical Device Plastic Moulding Ref: KDST A highly competent quality professional, with extensive experience in the quality function within the plastic injection moulding industry serving medical device sectors.  Most recent assignment acted as Operational & Quality Manager assisting in the transfer of manufacturing facility to new location following its acquisition  by acompetitor firm. Senior Operational Quality Interim Manager Ref: OLPCONH BSc PhD Chemistry Qualified Person Status(Q P) Over 20 years experience including holdinh senior management role bot Quality Control and Quality Assurance. Recent assignment include VP of Quality with responsiblities for all of the companies manufacturing opertions located in Europe and Asia. Hands-on management style with the ability to make a immediate impact in terms of directing change programs ensuring improvements in standards whilsts driving departmental efficiencies in both sSME's and larger manufacturing companies.   For more information on our Panel of Interim Managers & Technical Experts plesae email info@pharmaexecutives.com or telephone + 353 (0)1 2800430 Interim Technical & Management Staffing Services   Why Interims The benefits of using Interim Executives and Technical Staff How Interim Staff Services Works Price Cost of hiring Interims Quality Panel  General management Operations Production Directors Managers Envirnomental Health Safety Reach Temporary Executives Research Development Technology Commercialisation Technology Transfer Sales marketing Business development Export International Sales and Marketing Logistics Purchasing Materials Planning Distribution Supply Chain Transportation Medical Device Engineers Staff Directors Managers Mechanical Electrical Maintenance Polymer Plastic Packaging Metal Precision Engineering Material Science Corporate Finance Banking Life Science Healthcare Sectors Regulatory Affairs Registration Register your Details to join our Executive Panel O'Loughlin Partnership Executive Search Selection Regulatory Training and Compliance Quality Consultancy Services Life Science Training Services Compliance and Regulatory Affairs meeting FDA IMB MRHA WHO Authorities Pharmaceutical and Medical Device Supply Chain Regulatory and Compliance Training Good Distribution Practice Cold Chain Temperature Controlled Logistics GDP Distribution Transportation Airports Ports Freight Forwarders Logistics Storage Wholesalers PharmaCareers is specialist division of the O'Loughlin Partnership engaged in assisting individuals with career advisory and training seeking a career move to the Life Science Industry Pharmaceutical Medical Device Biopharmaceuticals Diagnostics Healthcare