Job Description

About the role

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.

Main Responsibilities

• 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.

You will need

• 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.

What\'s in it for you

At Booker, along with being a great place to work and giving you an opportunity to get on in your career, we also offer the following fantastic package of benefits:

• A Booker colleague card with 10% off purchases at Booker and double discount events up to three times a year.
• After 3 months service, a Tesco colleague discount card with 10% increasing to 15% off most purchases at Tesco for a 4 day period after every four-weekly pay day, ie. thirteen times a year. In addition to 10% off at Tesco Cafe and 20% off all F&F purchases.
• 10% off pay monthly & SIM only deals with Tesco Mobile for yourself, along with further great deals through-out the year.
• Up to 30% off car, pet and home insurance at Tesco bank. Terms and conditions apply.
• Free eye test when you spend \xc2\xa350 or more. You can also save 30% when you spend \xc2\xa350 or more on glasses, prescription sunglasses and contact lenses.
• 50% off health checks at Tesco Pharmacy.
• Exclusive access to discounted RAC breakdown cover rates
• An exclusive deals and discounts website saving you money on everyday purchases including a cycle to work scheme.
• After 3 months service, you can join our annual Save As You Earn share scheme which allows you to buy Tesco shares in the future at a discount.
• Retirement savings plan (pension) - save up to 5% and Booker will match your contribution.
• Life Assurance - You are covered for death in service life cover of up to three times annual pay
• Health and Wellbeing support and resources including our 24/7, confidential Employee Assistance Programme for you and your family.
• A great holiday package

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