PSU Deputy Quality Assurance and Technical Lead

Job overview

The PSU deputy Quality Assurance and Technical Lead is responsible for completing and coordinating quality assurance activities within the Parenteral Services Unit (PSU), ensuring compliance with Good Manufacturing Practice (GMP), regulatory standards, and Trust policies. The post holder will report to the PSU Quality Assurance and Technical Lead and accountable pharmacist.

The post holder will support the safe and effective preparation of aseptic medicines by maintaining the Quality Management System (QMS), overseeing Environmental Monitoring (EM) and validation programmes, managing quality investigations and audits, and supporting service developments.

Working closely with the PSU Quality Lead, pharmacists, pharmacy technicians, technical officers, Estates, Quality Control services and external contractors, the post holder will provide leadership on quality assurance matters and contribute to the continuous improvement of aseptic manufacturing services supporting cancer and haematology patients.

Main duties of the job

• To apply specialist knowledge ofqualiyt management systems, GMP, GDP and quality risk management principles.
• To ensure compliance with national pharmaceutical standards (QAAPs) and NHS guidance relating to aseptic preparation.
• To communicate effectively with individuals within Parenteral Service Unit, and other technical service departments across BFT.
• To develop own skills and knowledge and to support in the training and development of othe staff.
• Deputising for the PSU Quality Assurance and Technical Lead

Detailed job description and main responsibilities

Refer to Job Description and Person Specification.

The post holder will be required to work within specialist aseptic clean room facilities which we are required to operate under strict regulatory rules. The guidelines covering the operation of these aseptic facilities mean that staff members with certain long term or recurrent medical or health conditions, such as gastrointestinal or skin conditions, can represent a risk of microbial contamination which therefore precludes access to the clean room. For candidates’ information, our Occupational Health team will carry out an assessment at the stage when conditional offers are made. The assessment will consider whether any candidate would not be able to work in an aseptic facility and/or whether any candidate would be able to work in an aseptic facility with any restrictions or reasonable adjustments.

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.