Advanced QA/QC Specialist (XR07)

Job description

Job responsibilities

This post will work with the Pharmacy Quality Controller and QA Service Manager and QA Team Leader - Pharmacist in ensuring that all MHRA licensed medicine preparation and distribution within the facility at Moor House is carried out in accordance with relevant regulations and cGxP.

The post-holder will act as a Releasing Officer for the Pharmacy Manufacturing Unit (PMU) under the terms of the MHRA Specials Licence. This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit (APU). It also involves being responsible for the quality and safety of individual released batches of oral and topical preparations manufactured in the Dispensary Support Unit (DSU). Batches manufactured in this unit are supplied to LTHT and other users within the local Health economy.

The post-holder will work in partnership with the Pharmacy Quality Controller and QA Service Manager in ensuring that all unlicensed LTHT Aseptic and Radiopharmacy facilities are operating in accordance with current guidance and cGMP.

Provide input into the co-ordination, development and delivery of highly specialist education and training on aspects of Good Manufacturing Practice (cGMP) and other QA/QC practices and procedures within Pharmacy Preparative Services (including pharmacists, scientists, pharmacy technicians, and pharmacy support workers) and Trust wide where appropriate.

Co-ordinate and develop training programmes, where required, to complement areas of specialist knowledge, research and practice.

Manage staff providing specialised preparative and/or QC/QA services.

Utilise highly specialist knowledge, skills and experience to critically appraise deviations, analyse data and identify solutions to optimise technical processes and implement strategies for continuous improvement.

Under the leadership of the Pharmacy Quality Controller and QA Service Manager and the Preparative Services managers, ensure all records within the electronic Pharmaceutical Quality System are complete and accurate. Reviews and develops the system as required.

Performs and trains others to successfully perform quality investigations, risk assessment, root cause analysis, CAPA management and impact assessments.

Review, analyse and develop periodic Assurance Reports and associated data in relation to the Pharmaceutical Quality System as required, providing relevant guidance to service managers.

Undertake research to inform continuous improvement and innovation across the Preparative Service and beyond.

Provide highly specialist advice and guidance MMPS Preparative Service and the wider Medicines Management & Pharmacy Service.

Participate in evening, weekend and bank holiday rota and where appropriate, out of hours services.

Provide support for the Preparative Service Leadership team in the investigation and actions from errors and incidents and response to audits.

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

Contribute to the development and maintenance of a suitable training programme and delivery of this programme within MMPS Quality Control / Quality Assurance department.

Leads a team of technical and support staff in the Quality Assurance Service ensuring they have appropriate induction, regular appraisals, personal development plans and challenging but realistic objectives.

Conduct 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.

Provides operational support within Preparative Services, including sessional supervision, accuracy checking and product release. This will usually be on a planned basis.

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

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

Works with key stakeholders in ensuring the delivery of training and competency assessments for staff working within the preparative service, including supporting the assessment of STP Trainees.

Identifies and implements risk reduction strategies in Preparative Service areas, in support of the Preparative Services Management Team.

Develops efficient communication channels with the rest of MMPS and key customers, ensuring good understanding of the service and the roles and responsibilities of staff.

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

Leads the implementation of new changes, based on best evidence or expert scientific opinion.

Manages difficult problems including providing advice on production, COSHH issues and issues relating to safe use of unlicensed medicines. In some situations information may be ambiguous or limited and opinions may differ on preferred outcomes.

Undertakes quality assessment of unlicensed medicines.

Undertakes critical review of stability studies and related product literature.

Assists in Health and Safety Management.

Participates in research and development activities within speciality including formulation and product development.

Plans and performs GMP and GDP internal quality audits in MHRA licensed facilities and all other Preparative Services areas and takes action to remedy and deficiencies to continually improve the quality of the service.

Plans and performs Governance Audits in Preparative Services dispensing areas.

Provides scientific support and highly specialist advice to the MMPS Leadership team on a range of issues, including those outside the Preparative Service.

Supervises, teaches, and assesses junior pharmacy staff completing training modules within Preparative Services.

Person Specification

Qualifications

Essential

• Honours and Masters Degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences OR Masters degree in Pharmacy OR Post Grad Diploma in Pharmaceutical Technology or similar
• Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent body
• Relevant training in Batch aseptic production and Good Manufacturing practice
• Relevant training in Quality Management

Skills and Behaviours

Essential

• Able to cope with conflict and handle difficult situations

Experience

Essential

• Undertaking research, innovation and continuous improvement
• Highly specialist knowledge and experience to act as a Releasing Officer for relevant product types
• Root cause analysis
• Change management

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).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Leeds Teaching Hospitals

Address

Leeds Teaching Hospital

125 Moor Road

Hunslet

Leeds

LS10 2JQ

Employer's website

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