Leidos Europe, part of Team Leidos, are looking for a Medicines and Healthcare Responsible Person to join their team in Bristol. Team Leidos is honoured to support the UK MOD’s Logistic Commodities amp; Services Transformation (LCS[T]) programme, a critical effort to enhance and improve the UK’s defence supply chain. https://www.teamleidos.co.uk/about
The aim of this post is to provide a highly specialised level of Assurance, support and direction to professional and operational aspects of Good Distribution Practice (GDP) within Team Leidos within scope of the Wholesale Distribution Authorisation (WDA). This is in order to ensure the safe procurement, storage and distribution of medicinal products for human and animal use and protect end users against potential hazards arising from poor distribution practices within the WDA in a military setting in the United Kingdom and overseas, in peacetime and on Operations. Quality risk management procedures and policies should ensure that the evaluation of risk to quality is based on scientific knowledge, experience with the process and ultimately links to the protection of the patient. The post holder will be eligible to be registered as a Responsible Person (RP) with the Medicines and Healthcare products Regulatory Agency (MHRA) and will lead on policy and procedure development and implementation from GDP (UK and EU) regulations and legislation and GDP related audit. This work will inform and shape the overall Team Leidos pharmaceuticals procurement amp; Distribution strategy, which will assist and support Defence by providing the overarching framework to enable a safe and effective supply chain for Medicinal products. Responsibilities The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The duties of a RP include:
- Ensure that the provisions of the licences are observed and maintained including the monitoring, review and implementation of new and emerging legislation. The RP will be the prime point of contact for the MHRA, Home Office and other European Regulators as applicable.
- Ensure that the operations do not compromise the quality of medicines by ensuring that a robust and workable Quality Management System is in place and maintained to meet regulatory and customer requirements. To work closely with teams and functions to support incidents and take a proactive approach to providing effective solutions
- Oversee audit of the quality system and to carry out independent audits including the implementation and schedule adherence of a self-inspection programme.
- Ensure that adequate records are maintained
- Vendor evaluation and qualification of suppliers of Pharmaceutical products and 3PL providers.
- Ensure that all personnel are trained and aware of GDP requirements.
- Ensure full and prompt cooperation with product licence holders in the event of recalls.
- Responsible for the management and performance of the QMS, including strategic policy setting, continuous improvement, quality management reviews, risk management, change control, complaints, Deviation management, investigation and CAPA, self-inspection and generation of technical/quality agreements.
The Leidos Europe Ltd RP will lead, manage and develop the RP’s and deputy RP’s across Team Leidos and continually review ways of working to improve processes and procedures to deliver a GDP compliant Supply Chain across the businessQualifications:
Knowledge, skills amp; experience
- Eligible to be registered as a Responsible Person (RP) with the Medicines and Healthcare products Regulatory Agency (MHRA) for Human amp; Veterinary WDA.
- Eligible to be named on a Home Office Controlled Drugs License.
- Experience of the Military Supply Chain
- Detailed knowledge of current GDP Guidance/Legislation and some knowledge of current GMP requirements.
- Must be able to obtain a UK Security Check clearance.
- Registered Pharmacist or Pharmacy Technician
- Post-Graduate qualification in a subject related to Pharmacy, Procurement/Logistics, Quality or Project Management.
- General knowledge and experience of primary, community and secondary healthcare.
- In-depth knowledge of the legislation, regulations and guidance associated with the safe and effective procurement, distribution and storage of pharmaceuticals.
- Relevant experience of working amp; influencing at senior strategic level.
- Experience of dealing with highly complex and specialised Pharmacy related issues requiring analysis of information from a variety of sources.
- Experience of conducting GDP Audits
- Experience of Implementing and assuring Quality Management Systems
- Organisational skills with ability to manage multiple strands of work.
- Experience of facilitating change.
- IT literate in order to extract and present information from variety of sources.
- Able to travel to UK based locations
Leidos is a global science and technology solutions leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported pro forma annual revenues of approximately $10 billion for the fiscal year ended January 1, 2016 after giving effect to the recently completed combination of Leidos with Lockheed Martin's Information Systems Global Solutions business (IS GS). For more information, visit www.Leidos.com. The company’s diverse employees support vital missions for government and commercial customers. Qualified women, minorities, individuals with disabilities and protected veterans are encouraged to apply. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an Equal Opportunity Employer.