Overview
We are looking for a Deputy Quality Assurance Manager who will oversee the development, implementation, and maintenance of a robust Quality Management System across the Aseptic service, ensuring compliance with regulatory and accreditation standards to support safe and effective patient care. The post holder will promote quality assurance principles and embed these into routine clinical practice, working with multidisciplinary teams to ensure quality standards are understood, applied, and sustained across all services.
The deputy quality assurance manager will lead quality improvement initiatives, ensuring services evolve in line with regulatory requirements, audit outcomes, and best practice. This includes managing projects focused on compliance, service development, and patient experience.
Main duties of the job
- To support the QA Manager in building, developing and monitoring the quality systems applicable to the pharmacy service with a particular focus on Manufacturing and other registerable activity
- To review and approve quality documentation and systems including change management, GMP deviations, recalls, complaints, product defects, etc.
- To undertake and support the preparation of SOPs.
- To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment.
- To participate in internal quality audits (Production Unit and Stores and distribution) and external audits as required.
- To approve master worksheets, which relate to or might impinge upon licensable activities.
- Be responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records.
- To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch
- To support and where indicated lead investigations into deviations in quality processes.
- To contribute to external inspection requirements relating to GMP and GDP eg MHRA, CQC, GPhC.
- Ensure appropriate escalation of all risks and outstanding corrective and preventative actions. Maintain relevant records, ensuring accurate data input into all computerised systems.
Experience
- Science Degree
- 3 years working in QA position in a GMP environment
- 5 years working in a QA role in a MHRA regulated area
- Solid understanding of aseptic manufacturing
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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