Pharmacy Quality Control Team Manager (XR08)

Job description

Job responsibilities

The post holder will:

Be responsible for the management of all staff working in the QC service including recruitment, planning and allocation of workload and quality checking of work. They will be required to induct and train staff working in this service and manage any performance issues appropriately.

Manage the QC team in developing and delivering a highly specialist service to all operational areas within Pharmacy and Medicines Management at LTH and to external customers. This includes planning, allocation and quality checking of service workload.

Deputise for the Pharmacy Quality Controller and QA Service manager both as the Quality Controller and to ensure that the daily functions of the QA/QC service are delivered.

Act as:

a Releasing Officer for batches prepared in the licensed pharmacy manufacturing unit and repackaging facilities. This requires detailed

knowledge of the units facilities and a high level of Good Manufacturing Practice.

the Quality Controller for Medical Gas Pipeline Systems (MGPS) for the Trust and for other hospital trusts throughout the Yorkshire and

the Humber in accordance with standards outlines in HTM 02-01 to include the following:

- To assume responsibility got the quality control of medical gases at the terminal units.

- To liaise with the Authorised Person (MGPS) in carrying out specific quality and identity tests on the Medical Gas Pipeline System in

accordance with the permit-to-work system and relevant pharmacopoeia standards.

- To organise medical gas pipeline system training of pharmacy staff who may deputise of the QC (MGPS).

the Professional Secretary to the LTHT Medical Gases Committee including responsibility and oversight of the Trusts Medical Gas

Operational and Business Continuity Procedure.

Manage, organise and deliver:

a finished product checking service for all batches manufactured in the licensed aseptic manufacturing and repackaging units.

a continuous temperature monitoring system to ensure the appropriate storage of all medicinal products within the Medicines

Management and Pharmacy directorate.

a programme for medical gas testing within the Trust and to a wide portfolio of external customers.

a programme of stability testing for the department. This will involve the development of stability indicating assays and subsequent

accelerated and real time stability testing.

a programme of process qualification and validation for all laboratory analytical work, microbiological monitoring, physical environmental

monitoring and medical gas testing. To ensure that all testing is in compliance with appropriate standards

a quality assessment and analytical service to ensure that all raw materials and components used during aseptic or extemporaneous

preparation and manufacture are of suitable quality

a programme of microbiological environmental monitoring for pharmacy clean room production areas both within LTH and to external

customers.

a programme of physical environmental monitoring for pharmacy clean room production areas both within LTHT and to external

customers.

Provide:

performance oversight of the quality control service functions reporting to Pharmacy Quality Controller and QA Service Manager.

highly developed specialist expert advice relating to medicines testing, formulation, stability, environmental monitoring and medical gas

provision to the service managers of all licensed manufacturing and unlicensed preparation units at LTH.

expert opinion and advice relating to clean rooms, and clean room devices to the service managers of all licensed manufacturing and

unlicensed preparation units at LTHT and to external customers.

continual professional development training on QC matters to the department and Trust.

Ensure:

all analytical procedures, specifications and documentation conform to current standards.

compliance with current regulatory requirements including the Medicines Act and subsequent statutory Instruments, Health & Safety at Work Act and COSHH regulations and ensure safe systems of work in the laboratory.

all QC equipment is regularly serviced and calibrated as necessary and that records are maintained.

all samples submitted to the laboratory are tested to appropriate standards and that all site testing is in compliance with appropriate

standards.

robust policies and procedures are in place to effectively manage medicines and comply with national standards.

Be responsible for:

Individual and team performance through the setting of objectives, PDPs and appraisals. Also be responsible for sickness, disciplinary

and grievance matters and recruitment strategies including undertaking skill mix reviews and succession planning. To ensure that all staff working in the service are suitably trained for their duties and that training records are kept up to date.

Strategic service planning through capacity management, and cover plans by liaison with other sections within pharmacy and external to pharmacy

The continual review of pharmaceutical service provision to a range of departments and service managers. Where necessary, plan and implement changes to ensure that future service development needs are met.

For data and budget monitoring for the QC service including periodic review of service level agreements and management of the invoicing for all QC services provided to external customers.

Undertake and lead research activities of the individual and team, by identifying areas for audit and ensuring support from CSUs or Trust. The post holder will undertake and publish practice research and enable team members to do likewise.

To prepare and act as approved signatory for highly complex technical reports.

Support service managers in the implementation and maintenance of the centralised temperature monitoring system within MMPS. This will include staff training, carrying out performance reviews of cold storage devices, oversight over the annual calibration process and validation of new and existing devices.

Develop and maintain schedules and reporting systems for all QC activities. This will include the development of the following:

- a pre-planned calendar for routine testing

- a comprehensive reporting system of results to service managers

- a fast-track reporting system of any failures to service managers

- the provision of Quarterly activity summary reports to the Pharmacy Quality Controller and QA Service manager.

Identify the resources and staffing structure required to extend the Quality Control service to support all pharmacy and medicines management activities and provide an integrated quality system. This will involve working closely with the Pharmacy Quality Controller and QA Service Manager in submitting proposals for a QA framework across pharmacy and identifying the required resources for its implementation.

Person Specification

Skills & behaviours

Essential

• Team Player
• Enthusiastic
• Well motivated with a desire to achieve high standards in work
• Able to work under own initiative
• Be highly adaptive to changing circumstances and situations
• Meticulous attention to detail.

Experience

Essential

• Experience of workforce management, leadership, planning and allocation of workload.
• Ability to manage, lead and motivate team of scientists, technicians and support workers
• Extensive experience communicating challenging decisions or information to service users
• Summarise your experience working within a pharmaceutical Quality Control service.
• Provide relevant examples that demonstrate both your technical expertise and capability relating to Quality Assurance of a QC laboratory or service.

Qualifications

Essential

• Masters degree in Scientific discipline or equivalent level of knowledge and experience.
• Eligible for registration as QC(MGPS) for the testing of medical gas installations

Desirable

• Further qualification within Pharmaceutical Technology, QA, QC or analytical chemistry
• Registered QC for Medical Gas Pipeline Systems.Testing trained.

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

Employer details

Employer name

Leeds Teaching Hospitals

Address

St. James's University Hospital

Beckett Street

Leeds

LS9 7TF

Employer's website

https://www.leedsth.nhs.uk/ (Opens in a new tab)