Quality Assurance Specialist
Working in the Chief Pharmacist’s Office Innovation and Prescribing team, the role of the Quality Assurance Specialist is to support the Responsible Persons in ensuring that the quality and integrity of medicinal products are maintained throughout the distribution chain and to support the Responsible Persons to carry out their duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance and that public service obligations are met. The wholesale distributor must ensure that the Responsible Persons is adequately resourced in order to fulfil their duties and hence the need for a Quality Assurance Specialist.
About the opportunity
The L6 Quality Assurance Specialist reports into the L5 Good Distribution Practice Responsible Person and Lead for Home Office Controlled Drugs Licensing.
Key responsibilities for supporting the Responsible Persons include:
• Ensuring that a quality management system is implemented and maintained
• Focussing on the management of authorised activities and the accuracy and quality of records
• Ensuring that initial and continuous training programmes are implemented and maintained
• With regards to the documentation and information gathering required in relation to any recall operations relating to medicinal products
• Ensuring that relevant customer complaints are dealt with effectively
• Ensuring that all the relevant documentation is in place so suppliers and customers of medicinal products can be approved by the Responsible Persons
• Approving any subcontracted activities which may impact on GDP
• Ensuring that the documentation required for self-inspections and subsequent corrective measures is accurate and of a high standard
• Keeping appropriate records of delegated duties
• With regards to documentation relating to the decision on the final disposition of returned, rejected, recalled or falsified products
• With regards to documentation relating to approving any returns to saleable stock
• Ensuring that any additional requirements imposed on certain products by national law are adhered to
• In communications with and inspections by the national competent authorities for medicinal products (e.g. MHRA)
• Support the coaching and development of peers and colleagues in the wider CPO team
Ideally the role requires:
• Expert knowledge of Good Distribution Practice (GDP) together with the regulatory requirements for medicinal products in Europe
• Extensive experience of using and maintaining a Quality Management System (QMS)
• Relevant GDP experience
• Proven leadership experience
• Ability to work collaboratively as part of a team
• Proven ability to understand complex problems and facilitate solutions (demonstrating due regard to potential risk for the business and the ability to use personal influence to ensure that appropriate decision-making is achieved)
• Excellent communication skills, verbal and written with sound attention to detail
• Ability to operate with autonomy and limited supervision
We have a great range of benefits* that go beyond salary and offer flexibility to suit you:
• Competitive holiday allowance (with the option to buy more days)
• Boots Retirement Savings Plan pension scheme
• Discretionary annual bonus scheme
• Enhanced Maternity / Paternity / Adoption leave pay
• £100 gift card for colleagues expecting/adopting a baby
• Flexible benefits scheme (via salary sacrifice) including financial wellbeing support, gym membership, holiday buying, dental cover, life assurance, restaurant discount cards, activity passes and much more (exclusions may apply, eligible roles only)
• Access to our Employee Assistance Programme offering free, independent and confidential counselling and support, 24 hours a day, 7 days a week
• Generous staff discount (with enhanced discounts for Boots brands, Boot Opticians and Boots Hearingcare)
• Access to corporate third-party discounts, including retail, cinema, holidays and more (UK only)
• Access to the Boots Benevolent Fund, a registered charity that offers support to eligible current and former colleagues in the UK, as well as their immediate relatives, at times of financial hardship.
• Access to a range of learning and development resources and programmes
• Excellent onsite facilities including: staff shop, opticians, gym, coffee shops, cafeteria, outdoor seating spaces, dry cleaning service and excellent travel links including on campus bus stops
*All rewards and benefits are subject to change and eligibility.
Our mission is to help everyone to feel good. This starts internally – with every colleague and every team. In our stores and pharmacies, our warehouses and our Support Office, we work together, putting our customers first and our colleagues at the heart of everything we do. We aim to attract, develop and retain the best people, with a huge range of opportunities for you to continue to grow with us… just bring your passion and commitment and we’ll do the rest.
Diversity, equity and inclusion is at the centre of everything we do in our business. We are proud to be an equal opportunity employer, passionate about embracing the diversity of our colleagues and providing a positive and inclusive working environment for all.
At Boots we're proud to offer our Support Office team members a hybrid working approach because how we work is central to our ability to compete, innovate and win together. Our hybrid, flexible approach to work is based upon empowerment, accountability, care and trust and includes a balanced mix of remote and office-based working.
If your application is successful, our in-house recruitment team will be in touch to arrange an interview and to answer any initial questions you have. If you have not been successful on this occasion you will be notified by email.
If you have any questions about this vacancy, please contact firstname.lastname@example.org
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