QA/QC Specialist (XR06) - #1730306

Ensures aseptic preparation is carried out efficiently and responsively and in compliance with current legislation and standards and the principles of Good Manufacturing Practice. Ensures equipment and facilities are subject to an appropriate programme of validation Ensures (in liaison with service managers) that the following are undertaken. - Physical and Environmental Monitoring - Operator and Process Validation - Audit (and subsequent action planning) Leads a small team of technical and support staff, as required, in the Quality Assurance Service 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 limited recruitment and selection of technical and support staff within the service 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 to the service, including sessional supervision and accuracy checking +/- final product approval. 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. Participates in regular internal audits of the service and take action to remedy and deficiencies to continually improve the quality of the service. 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 NVQ candidates. 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. Identifies and implements risk reduction strategies in preparative service areas, in support of the Preparative Services Leadership Team. Develops 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 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 Quality assessment of unlicensed medicines Critical review of stability studies and related product literature Professional Release of Licensed Batch Manufacture - This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit under the terms of the MHRA (Medicines & Healthcare Regulatory Agency) Specials Licence.

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 under the terms of the MHRA Specials Licence. Products prepared in this unit are supplied to LTHT and other users within the local Health economy including Local Care Direct and local health Trusts. Supports the QA/QC management team in ensuring that all licensed medicine preparation within the Trust is carried out accordance with cGMP. Final Accuracy Checking +/- final product approval in the unlicensed aseptic dispensaries 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 audits in MHRA licensed facilities and all other Preparative Services areas. Plans and performs Governance Audits in Preparative Services dispensing areas. Provides scientific support and 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