Pharmacy Quality Assurance Specialist

4 weeks ago

Preston, United Kingdom Lancashire Teaching Hospitals Full time

Job overview

We have a fabulous opportunity for a Temporary 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 Science Trainee Program graduate or Pharmacist

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

Main duties of the job

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

This is an exciting time for Aseptic, Production and radio Pharmacy Services with NHSE’s future plans for transformation and investment. The post holder 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.

Working for our organisation

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.

Detailed job description and main responsibilities

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 team member, essential for creating, improving and sustaining the safety, quality and efficiency of our services and 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 Management and Control of the overarching Pharmaceutical Quality Management system (PQS) for PMU

Person specification

Qualifications & Education

Essential criteria

Masters degree in Pharmacy OR Honours degree in pharmaceutical sciences, chemistry or similar scientific subject if combined with further education and training such as the Scientist Training Programme (STP) Highly developed Professional knowledge, underpinned by theory and experience

Desirable criteria

Technical qualification such as Pharmacy, Pharmaceutical Technology, Quality Control, Engineering, Manufacturing. Post graduate certificate or diploma in a relevant pharmaceutical field. GPhC registration

Knowledge & Experience

Essential criteria

Knowledge of Good Manufacturing Practice and the regulations surrounding Pharmaceutical Manufacture. Knowledge of clean room design and functioning Experience of product development Evidence of working within GMP/GDP guidelines COSHH Regulations and Health & Safety at Work Act.

Desirable criteria

Experience of Pharmaceutical Manufacture in either a hospital or industrial environment or previous experience of managing aseptic dispensing services. Specialist knowledge of Pharmaceutical Manufacturing Processes including equipment and facility design, construction, validation and testing. Knowledge of: Aseptic preparation of medicines, Terminal Sterilisation processes, Non Sterile Product Manufacture (all dosage forms excluding tablet and capsule manufacture) An understanding of medicines management procedures Knowledge of product licensing and medical devices registration Knowledge of the ISO 9000 Quality System

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