We have a new, exciting role here at Booker for a Responsible Person (Medical) to Join our Technical team.
The role is based in our Wellingborough head office and offers hybrid working. The role involves extensive travel across the UK to oversee site operations.
As a Responsible Person (RP) you will be required to develop and implement quality systems and operational plans for Booker Group’s management of the wholesale of medicinal products, in compliance with the Wholesale Distribution Authorisation, referred to as WDA(H) requirements, Guidelines on Good Distribution practice (GDP) and published MHRA guidance.
- Ensuring that the conditions under which the Booker Group licences/WDA(H)s, were granted are continually complied with.
- Ensuring that the quality of medicinal products handled by Booker Group entities are maintained in accordance with the requirements of the applicable marketing authorisation(s).
- Enhancing, implementing and maintaining the quality management system (QMS) to maintain compliance with the WDA(H) requirements. Ensuring medicinal products are procured, stored and supplied in a manner compliant with the established QMS and a change control system is in place to manage changes are effectively.
- Proactively leading continuous improvement across multiple site operations.
- Devising, implementing and maintaining an effective GDP training programme for staff involved in WDA(H) operations.
- Providing leadership and direction on issue management to ensure deviations and/or all quality issues are fully investigated and the appropriate corrective and preventive actions (CAPAs) are taken to correct and prevent recurrence.
- Ensuring there are adequate processes and controls in place for approval of WDA(H) suppliers and customers, and where applicable transport providers are assessed and the relevant Technical Agreements put in place.
- Supporting the licence holder by Coordinating and promptly acting to completion any recall operations for medicinal products.
- Ensuring that any product and service complaints are handled effectively in accordance with the documented MHRA procedures.
- Document management complying to the WDA(H) operations, and GDP requirements including control, accuracy, availability and maintenance.
- Approving any subcontracted activities that may impact on the WDA(H) licences/GDP.
- Ensuring that inspections across the Booker Group sites are performed at appropriate intervals and the necessary corrective measures are put in place; attending and carrying out these inspections where necessary.
- Accurate recording of any delegated RP responsibilities.
- Deciding on the final disposition on product quality issues including but not limited to returned, rejected, recalled, or falsified products.
- Ensuring that Booker and associated companies comply with any additional requirements imposed on certain products by national law. Co-ordinating, hosting and following-up relevant audits by the MHRA, Internal Audit and external partners.
- At least two years practical experience within the wholesale of medicines, covering multiple complex sites, ideally MHRA registered.
- Completion of the Cogent Gold Standard RP Training, or willingness to obtain this qualification.
- Relevant provisions of the Human Medicines Regulations 2012 and amendments.
- Knowledge of GDP within the medical industry.
- Knowledge and experience of storage condition, temperature control and transportation for medical products.
- Knowledge of quality management of risk, change, deviations, and outsourced activities.
- Provide leadership and delivery of the licensed WDA (H) functions.
- Experience of logistics/warehouse management
- Excellent interpersonal, communication and influencing skills, able to successfully manage stakeholders.
Shift Hours: 38 hrs per week (Monday-Friday)