University Hospitals Birmingham NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust (UHB) are pleased to offer a rare and exciting opportunity for the role of Quality Assurance (QA) Manager for pharmacy.
We are seeking an experienced and motivated Pharmacy Quality Assurance Manager to join our dedicated team. As part of a dynamic and innovative Trust, you will play a vital role in ensuring the highest standards of quality, safety, and compliance within our pharmacy aseptic services.
The Pharmacy Aseptic Services at UHB prepare and dispense aseptically prepared systemic anti-cancer medicines (SACT), monoclonal antibodies (MABs), Clinical Trials, outpatient antibiotic therapy (OPAT) and radiopharmaceutical treatments to UHB and external customers. There are three aseptic facilities across UHB, including an unlicensed unit located at Heartlands Hospital, a licensed unit located off-site at our Melchett Road facility, and a licensed Radio pharmacy (RPh) facility located at QE Hospital.
Join us at University Hospitals Birmingham and be part of a team committed to delivering exceptional patient care and services. Apply today to make a difference!
Main duties of the job
To provide leadership and delivery of Pharmaceutical Quality Assurance services to the Trust, including but not limited to:
1. Batch and patient specific manufacture of ready to administer products, including systemic anti-cancer treatment (SACT), high-risk injectables, and radiopharmaceuticals, for the Trust and external customers under license.
2. Aseptic dispensing of systemic anti-cancer medicines (SACT), high-risk injectables, and Outpatient Antibiotic Therapy (OPAT) under Section 10 exemption.
3. Assembly of products such as over-labelling.
4. Senior line management to all QA staff.
To be named on the Trust's Manufacturing Specials License as the Trust's Head of Quality. Duties include:
1. Authorisation of all systems of work and documentation in the aseptic units, radio pharmacy, and other licensed areas (e.g. over-labelling).
2. Oversee the design, implementation, and maintenance of the Pharmaceutical Quality Systems (PQS) ensuring requirements of cGMP and consequently the MHRA are met.
3. Ensure adherence to the PQS through appropriate training and motivation of pharmacy production and QA staff.
4. Ensure continuing adherence to the requirements of PQS and cGMP through regular internal inspections and report compliance via the Pharmacy Senior Leadership Team.
About us
We are recognised as one of the leading NHS Foundation Trusts in the UK. Our vision is to Build Healthier Lives, and we recognise that we need incredible staff to do this.
Our commitment to our staff is to create the best place for them to work, and we are dedicated to:
* Investing in the health and wellbeing of our staff, including a commitment to offering flexible working where we can.
* Offering our staff a wide variety of training and development opportunities to support their personal and career development objectives.
UHB is committed to ensuring that our staff are treated fairly and feel that they belong by creating a kind and inclusive environment. This is about equity of opportunity; removing all barriers, including discrimination and ensuring each individual member of staff reaches their true potential, achieves their ambitions, and thrives in their work. This is more than words. We are taking action. Our commitment to an inclusive culture is embedded at all levels of the organisation where every voice is heard, driven by our diverse and active staff networks, and at Board level by the Fairness Taskforce led by our CEO. We nurture a culture that empowers staff to challenge discriminatory behaviours and to enable people to bring their 'whole self' to a kinder, more connected, and bold place to work.
University Hospitals Birmingham is a Smoke-Free premises hospital.
Job responsibilities
*Please Note: For a detailed job description for this vacancy, please see attached Job Description*
Person Specification
Qualifications
* MSc Pharmaceutical Technology and Quality Assurance or equivalent
* Eligibility for Qualified Person Status under European Statutory Directive 2001/83/EC Article 51
* Registered with GPhC or member of equivalent professional body.
Experience
* Substantial experience as a quality assurance practitioner
* Substantial experience in leading on the preparation for external audits by MHRA or Regional Quality Assurance.
* Experience in preparing evidence portfolios for NHSLA, CQC, and MHRA standards
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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