Quality Project Specialist

2 weeks ago

Cambridge, United Kingdom nhs blood and transplant Full time

**Quality Project Specialist**

**Job Summary**

This is an exciting opportunity to support innovative projects to develop new blood components within a challenging regulatory environment. There’ll be some time behind a desk; but a requirement to be present at the NHSBT Cambridge site, where these projects are centred (an average of at least one day per week) to perform some of the duties of this role. With excellent communication and influencing skills you will be expected to build good working relationships with individuals working within the Component (Blood) Development Laboratory (CDL) to ensure product safety and compliance requirements are understood and adhered to. Given the need for awareness and adherence to statutory requirements you will have considerable previous experience working in Quality Assurance or a regulated life science / healthcare environment. MSc Degree qualified, or equivalent experience, you will also have a working knowledge of relevant standards such as the Blood Good Practice Guidelines and Pharmaceutical Good Manufacturing Practice.

It’s important you’re also a consummate professional who can build strong relationships and ask the right questions while keeping an objective view of the work.

**Main duties of the job**
- Provide regulatory support for key CDL projects, notably in the planning and execution of validation and qualification activities.
- Provide day to day Quality Management System (QMS) support to key individuals within CDL (and potentially in other functions) including advice and guidance on QMS Change Control, Validation, Quality Incident Management, Root Cause Analysis, Document control and preparation and Provide advice, guidance and support surrounding supplier management
- Assist the wider Quality Assurance Team in the implementation and management of national initiatives and to support the Lead Quality Specialists (LQS) in their directorate and national activities.
- Be required to travel and, with prior notice, spend time away from base, which will involve working irregular hours and overnight stays when required.

**About You**

**Experience and Knowledge**
- Relevant experience in a regulated environment e.g. Good Pharmaceutical Manufacturing Practice (GPMP), or equivalent
- Experience in quality at a senior management level
- Knowledge of Medicines legislation (GPMP), EU Blood Directives and law
- Knowledge General Data Protection Regulations (GDPR), freedom of information & Customer Protection Act
- Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), or equivalent Systems

**Qualifications and Training**
- MSc in transfusion or transplantation or relevant science and examination via a professional body e.g. FIBMS or diploma from British Blood Transfusion Society (BBTS) OR equivalent specialist knowledge gained by experience
- Demonstrate commitment to own Continued Professional Development (CPD)

Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification for the full personal attributes we require for the role. You will need to demonstrate these throughout the recruitment process.

**About Us**

At NHS Blood and Transplant, we’re incredibly proud of the many talented people who come together every day to make our organisation the very best it can be. We have clearly defined values that are centred around offering exceptional care to our donors and their families. We take care of each other too and we focus on building our expertise so we can change lives, provide quality support and offer fulfilling careers.

It’s an opportunity to contribute to a unique team as part of a service that saves lives 365 days a year. We offer brilliant benefits including 27 days of holiday (plus bank holidays), a comprehensive induction and training programme, and competitive pension scheme.

Three small words, one big difference - **Caring, Expert** and **Quality**.

Together we'll save and improve more lives than ever

This vacancy will close at 23:59 on Tuesday 25th April.

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