Senior Quality Assurance Specialist

3 months ago

Preston, United Kingdom Lancashire Teaching Hospitals NHS Foundation Trust Full time

We have a fabulous opportunity for a Senior Quality Assurance Specialist to join our team in the Pharmacy Manufacturing Unit in Lancashire Teaching Hospitals NHS Foundation Trust. This post would be suitable for a Pharmacist, Science Trainee Program graduate or other professional with relevant QA training and experience.

The PMU operates under the name of Preston Pharmaceuticals and encompasses Non Sterile Medicines manufacture, assembly, Radio pharmacy and Aseptic Services, to meet the clinical needs of patients both at the Trust and across the NHS.

This role will focus on ensuring the effective and efficient quality assurance of preparation, manufacture and assembly of unlicensed medicines produced within the PMU.

We are seeking a motivated individual who demonstrates commitment,
accountability and is a positive role model for our Quality Assurance and wider Teams.

You will have excellent capabilities to work as a senior team member, essential for creating, improving, and sustaining the safety, quality and efficiency of our services. Implement and manage the Quality Management System to ensure we maintain compliance with Good Manufacturing Practice, regulatory and legislative requirements.

**Integral to the role will be**:

- Acting as ‘Releasing Officer’ within the licensed (MS) areas
- Adherence with the overarching Pharmaceutical Quality Management system (PQS) for PMU.
- Provision of leadership with regards to all operational quality aspects

This is an exciting time for Aseptic Services with NHSE’s future plans for
transformation and investment. You will contribute in helping to inform and shape aseptic services for the Trust and across the ICS in the advent of future hub and spoke models, ensuring that quality assurance and patient safety will be at the heart of everything to we do.

We value the personal skills, experiences and qualities that individuals bring to our department and the Trust; creating an inclusive working environment to attract talented people who feel motivated, involved and able to influence the future direction of our services.

The wellbeing of staff is important to us; we have a dedicated Health and Wellbeing team who provide support on a range of topics, run fitness classes and organise mindfulness sessions. As an employer we have earned a reputation for focusing on the development of our staff and for being an organisation people are proud to work for.

**Duties will include, but not be limited to**:

- To lead the Quality Assurance service to ensure adherence to current legislation and standards.
- Perform investigations identifying root causes and corrective and

preventative actions.
- To organise and participate in audit and inspection.
- To arrange and manage the validation program.
- Organise and deliver staff training.
- Write and develop policies and procedures.
- Perform trending of data and produce written reports.
- To communicate with all members of the Aseptic and Non-sterile Teams, and regulators.
- To organise and participate in meetings.
- To act as a releasing officer for products prepared under the MS Licence.

For more details or to arrange and informal chat, please contact Martin Timmins on 01772 522220

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