Quality Assurance Manager – Technical Services
Nottingham University Hospitals NHS Trusts
The Pharmacy Quality Assurance (QA) team is responsible for driving quality within the whole of Pharmacy Technical Services, which includes the Sterile Production, Non-Sterile Production, and Prepacking Units, Pharmacy Stores, Quality Control and Quality Assurance functions based at QMC and Cytotoxic Chemotherapy Laboratory on the City Hospital Campus.
The post holder will support the Head of Quality with all aspects of QA to ensure that the service is fit for purpose. This will be achieved by taking a lead role in developing and implementing an effective Quality Management System (QMS); and managing the QA team.
The post holder will provide Quality Assurance leadership and support to all licensed and unlicensed production facilities, QC laboratory, and areas covered by the Wholesale Dealing Authorisation, in accordance with the strategic framework as defined by the Head of Quality. They will also develop and implement the QMS within the Radiopharmacy Department to enable integration of all sections of Technical Services.
The post holder will lead the QMS development, by providing leadership, support, expert advice and guidance. They will be expected to deliver on a range of projects and lead on the development of wider Quality Assurance issues.
The post holder will be expected to liaise with regulatory bodies such as the MHRA and Regional Quality Assurance Specialists, as well as NUH and non-NHU clients and senior members of the Pharmacy team and Clinical Support Division.
Main duties of the job
* To support the Head of Quality in developing and maintaining the QA services to a standard that can safely meet the Trust and patients needs and maintain the relevant MHRA licences held.
* To develop, implement and manage the Quality Management System for Pharmacy Technical Services, to include but not limited to deviation management, change control, complaints and corrective and preventative actions.
* To develop and monitor quality indicators to critically assess the Quality Management System ensuring the principles of continuous quality improvement are maintained.
* To compile and collate information and lead the designated team responsible for investigations of quality exception reports.
* To track and establish trends in quality exception reports and ensure identified trends are escalated.
* To develop and manage the Documentation Management System, ensuring that all required documentation is available and accurately reflects the actual practices undertaken.
* To respond to customer complaints and undertake drug defect investigations for NUH manufactured products.
* To support senior Production and Quality Control staff in monitoring available capacity to ensure adequate staffing resource is available.
* Work closely with cross-functional teams responsible for manufacturing, quality assurance, suppliers/service providers, Finance and clinical services to ensure correct reporting of data and resolve any queries.
* To develop and maintain the Validation Master Plan in conjunction with senior production and Quality Control staff.
* To monitor compliance and timely completion of validation activities to ensure the key objectives of the Validation Master Plan are met.
* To maintain Quality Assurance records, both paper and electronic, in compliance with current guidance, data integrity and legal responsibilities.
* To develop and maintain the internal audit programme.
* To monitor compliance and timely completion of audit activities.
* To carry out regular internal audits as part of the team of designated auditors to ensure compliance with GMP and GDP.
* To participate in external inspections carried out by MHRA or SPS QA Specialists to ensure ongoing regulatory compliance.
* Provide a source of expertise and guidance on procedures for all Quality related disciplines in line with MHRA Guidelines, EUDRALEX Vol 4, PIC/S, Quality Assurance of Aseptic Preparation Services (QAAPS) and NHS Yellow cover documents.
* Keeping abreast of MHRA regulatory/ICH standards, requirements and GxP procedures/policies and undertaking the implementation of these policies.
* To collate audit findings (internal and external) and lead on the development and implementation of action plans in response to identified deficiencies.
* To develop and support the implementation of appropriate Quality Assurance training programmes for pharmacy staff.
* To maintain and develop links with relevant professional bodies and organisations e.g. General Pharmaceutical Council, Medicines and Healthcare products Regulatory Agency, Specialist Pharmacy Services.
* To act as a Releasing Officer where necessary for manufactured, repackaged and overlabelled products under the MHRA (Specials) Licence.
Person Specification
Training & Qualifications
* Educated to a minimum of Degree level in Biology, Chemistry, Pharmacy or a related subject.
* Substantial post qualification relevant GMP experience and QA knowledge acquired through training to Masters degree or equivalent level of knowledge.
* Eligible to be a member of one of the Professional bodies (Chemistry, Pharmacy, and Biology).
Commitment to Trust Values and Behaviours
* Must be able to demonstrate behaviours consistent with the Trust's behavioural standards.
Experience
* Experienced in leading highly complex projects, extensive experience in the development of Pharmaceutical Quality System, processes and procedures including application of quality risk management principles.
* Broad understanding of MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors and ICH / PIC/S guidelines.
* Quality Control experience, including experience as a releasing officer.
* Experience in Pharmaceutical Quality Management Systems and Pharmacy Production experience working under Section 10 of the Human Medicines Regulations or an MHRA licensed facility.
Communication and Relationship skills
* Ability to provide and receive highly complex, sensitive and contentious information, negotiate with senior staff and external stakeholders on difficult and controversial issues.
* Experience of leading/managing teams and the ability to build successful teams.
* Ability to influence and motivate staff to deliver challenging targets.
Analytical and Judgement skills
* Able to analyse data for trending purposes and to produce management reports.
* High level of problem-solving skills and ability to advise clients and Pharmacy managers on all aspects of Quality Assurance.
Planning and organisation skills
* Able to develop and manage a Quality Management System and plan the workload to meet deadlines.
Physical skills
* Demonstrates a high level of attention to detail.
Other requirements specific to the role
* Candidate should be able to drive to other sites to conduct/participate in audits and may be expected to be on call for medical gases.
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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