Advanced Production Specialist

Job summary

Expected Shortlisting Date

01/10/2024

Planned Interview Date

10/10/2024

This is a great time to join the team as we are a national pathfinder (there are only 5 others in England) to build a new pharmacy aseptic medicines hub which will support the West Yorkshire Association of Acute Trusts (WYAAT).

If you are an enthusiastic and a self-motivated pharmacy technician or production specialist with a passion for Technical Services and can demonstrate high professional standards, this is the role for you. Youll need a keen interest in clean rooms, Hydrogen Peroxide gassing technology and have Pharmaceutical Quality System management experience and knowledge. You must be able to react to early response events which occur with key equipment and facilities. Youll be responsible for the re-validation of equipment and operators and participate in the delivery of key technical training to new staff and lead on service improvement.

We are based in south Leeds and operate under an MHRA specials licence providing high quality pharmaceutical IV medicines to patients.

The post is a full-time post of hours per week, to be worked over a 4 /5 day working week between the hours of 7am-7pm. This post has a weekend and bank holiday commitment on a rota basis.

Interviews will be held on 10th October 2024

Main duties of the job

To act as the lead for the Quality Assurance and MHRA legislation in the Pharmacy Manufacturing Unit within Pharmacy Preparative Services.

Manage service productivity, quality and safety according to Key Performance Indicators, considering safe staffing and equipment capacity limits.

Support the Production Manager to lead all production elements of the Pharmaceutical Quality System (PQS) underpinned by the Electronic Management System (EQMS)

Be responsible for ensuring that the legal and statutory requirements are met regarding facilities, equipment, policy, procedures, and training.

Participate in regular Internal Audits including Health and Safety Audits and follow up actions.

You will need advanced knowledge and understanding in the principles of GMP & GDP.

To work with the Pharmacy Preparative Services Management Team (PPSMT) to ensure the smooth implementation of new, education and training focused, Information Technology systems and procedures within pharmacy preparative services.

Line management of staff including Pharmacy Technicians and Production Specialists.

As part of the PPSMT, work closely with the Production Manager, the Aseptic Service Manager and the Radio pharmacy Manager in the development and planning of the service, with a focus on workforce development and training.

To perform a leadership role at weekends and bank holidays.

About us

Leeds Teaching Hospitals is one of the biggest NHS Trusts in the country, offering a range of both general and specialist hospital services with excellent clinical outcomes for patients. We have an international reputation for excellence in specialist care, research, and academic training.

The Pharmacy Department at LTHT is highly respected, forward thinking and recognised within the organisation for collaborative working.

The department is expanding to build a new Pharmacy Aseptic Medicines Hub which is part of a national programme to transform aseptic services in England. WYAAT has been identified as a pathfinder site for the programme which will oversee the implementation and operation of a new aseptic facility to supply large volumes of injectable medicines to WYAAT organisations. Its an exciting time to join our supportive and dynamic team to deliver real change and to make a difference to patient care.

Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.

Job description

Job responsibilities

This post will have the following duties / areas of responsibilities:

Ensures aseptic batch manufacture is carried out efficiently and responsively and in compliance with current legislation and standards and the principles of Good Manufacturing Practice.

Ensure equipment and facilities are regularly maintained, inspected and any deficiencies dealt with promptly, this includes oversight of validation and monitoring activities.

Manages the Production Specialists / Pharmacy Technicians.

Act as a professional role model for direct reports and wider department

Supports the Production Manager in the development and planning of the service.

Supports the Production Manager to investigate and implement actions from errors and incidents and response to audits, this can be complex required advanced skills relating to analysis and interpretation of data and information

Contributes to service development and supports effective change management within their own team and across all of Pharmacy Preparative Services.

Ensures that agreed stock control procedures are in place and followed.

Ensures (in liaison with QA/QC team) that the following are undertaken.

Physical and Environmental Monitoring

Operator and Process Validation

Lead team of technical and support staff in the Production Manufacturing Unit ensuring they have appropriate induction, regular appraisals, personal development plans and challenging but realistic objectives. Conducts sickness and disciplinary reviews as required.

Ensure Trust Absence Management policy is adhered to and that staff absence is reported and return to work interviews conducted in a timely manner.

Responsible for recruitment and selection of technical and support staff.

Ensures regular team briefings and meetings are held and that there is good communication for all staff using a variety of means, written and verbal.

Provide operational support to the service, including sessional supervision and accuracy checking. This will usually be on a planned basis.

Responsible the management of the weekend and bank holiday rota for preparative staff.

Always maintain high professional standards and ensure compliance with statutory regulations concerning pharmaceuticals and the provision of Health and Safety at work are complied with.

Work with Production Management Team in developing capacity and contingency plan for Production Manufacturing Unit. This can be complex as several variable factors such as demand, the availability of stock, staff competency levels and physical resource (, isolators) must be taken into consideration and can change at short notice.

Maintain and develop statistical data for performance monitoring of the Production Manufacturing Unit.

The post holder will analyse performance and productivity reports for their team and use this to influence change and contribute to improvements across the service.

Promote the cost-effective use of equipment and supplies and to ensure that appropriate ordering and costing procedures are in place.

Key member of the Production Management team for the Trust, contributing to planning and development of the Production Manufacturing Unit.

Participate in regular internal audits of the service and take action to remedy and deficiencies to continually improve the quality of the service.

Works with Advanced Production Specialist Education and Training in ensuring the delivery of training and competency assessments for staff working within the aseptic service, including supporting the assessment of NVQ candidates.

Contribute to pharmacy service developments and ensure that change is managed smoothly in relation to area of responsibility.

Identify and in conjunction with Production Management team implement risk reduction strategies in aseptic dispensaries.

Develop efficient communication channels with the rest of pharmacy and key customers to ensure a good understanding of the service and the roles and responsibilities of staff. This post holder will have a close working relationship with the Quality Assurance Team.

Person Specification

Qualifications

Essential

BTEC in pharmaceutical science or NVQ level 3 in pharmacy services or Science Manufacturing or Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology or similar discipline BTEC/Certificate in Aseptic Dispensing or Quality Assurance or equivalent Aseptic preparation / manufacture and Good Manufacturing practice

Desirable

Management / training / education qualification or evidence of formal management training

Experience

Essential

Significant experience of Pharmaceutical Manufacturing / preparation of aseptic medicines and leading a pharmaceutical workforce. Substantial post qualification experience of hospital pharmacy, including at specialist pharmacy technician team leader level and comprehensive experience in aseptic dispensing / processing

Desirable

Developing and implementation of procedures Development of risk assessments

Skills & behaviours

Essential

Commitment to high standards of service delivery

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