HealthJobsUK

Detailed job description and main responsibilities

Measurable Result Areas

• Maintain the QMS spreadsheets
• Assist in the development, implementation and maintenance of an effective Quality Management System.
• Participate in relevant document control and policy writing.
• Participate in routine communication with external QC contractors.
• Supervise and monitor routine pharmacy quality assurance activities, environmental monitoring, facility and equipment validation and planned preventative maintenance.
• Supervise and monitor the procurement and storage of raw materials, components, consumables and final products within the Aseptic Unit.

• To undertake physical and environmental monitoring of specialist clean room environments, including production of monitoring reports

• Interpret monitoring results and report quality concerns to the Accountable Pharmacist/Production Manager and Quality Lead.
• Participate in the reporting of near misses, deviations and complaints, with the subsequent generation and investigation of reports under the supervision of the Quality Lead.
• To trend and feedback to the National Aseptic Errors Reporting Scheme (NAERS) under the supervision of the Quality Lead.

• To respond appropriately to drug alerts and product defects (medicines and consumables) by participating in the reporting of recalls and complaints and the subsequent investigation under the supervision of the Quality Lead.

• Participating in the change control process and the subsequent generation and investigation of reports under the supervision of the Quality Lead.
• Participate in Quality Assurance (QA) audits and the implementation of actions required to address deficiencies
• Participate in the MHRA Licensed inspections and closure of items on the resulting action plan.
• Participate in the Farwell Audits and closure of items on the resulting action plan.
• Undertake validation activities as required
• Develop own knowledge of GMP and QA and participate in staff training, development and accreditation.
• Identify cost pressures on QA services and advise on options for dealing with them.
• Maintain PQ folders
• To take part in completing and actioning CAPAs where needed.
• Review ongoing costs of the environmental monitoring and staff validation programmes and identify potential cost savings.
• Identify areas of development for the Quality Assurance service
• Source stability information for new products in line with Yellow Cover Document requirements, for review by the Quality Lead.
• Be familiar with and apply knowledge of COSHH and Health and Safety regulation.
• Promote and support the development and implementation of evidence-based practice for all staff.
• Develop and coordinate activities relating to Pharmacy key performance indicators including a program and schedule of audits to monitor performance and adherence to Policies and Procedures.
• Promote and maintain effective communication as well as disseminate information related to practice development.

• Check microbiological plates and provide advice with regards to the results.
• Follow Standard Operating Procedures and all relevant regulations in the course of duties.
• Inspect, assess and release products produced by the licensed manufacturing unit.

• Investigate any temperature monitoring deviations and trend analysis of medicines storage.

• Work independently within the constraints of your abilities
• Undertake quality assessments of products manufactured in-house and purchased for use in the Trust.
• Undertake risk assessments where required.
• Support the COSHH Specialist Adviser with COSHH assessments, training and administration.
• Work within Trust and local policies and procedures and to report any non-compliance to the Principal Technician – Technical Services or Principal Pharmacist – Cancer and Aseptic Services

• To be responsible for the day to day management of equipment and clean room device maintenance and testing. This will include:
  • planned preventative maintenance,
  • equipment calibration,
  • troubleshooting and remedial action,
  • maintaining an equipment & device fault register and prioritising workload,
  • provision of reports and recommendations,
  • liaison with external service contractors
  • witnessing of validation, maintenance and testing.

• Maintain a clean and tidy environment and abide by the policies on security of drugs and premises and on the confidentiality of patients and staff.
• Meet the required commitment to personal CPD through continuing education and attendance at appropriate courses and study days.
• Maintain aseptic manipulation skills so as to be aware of issues, to understand the background and participate in the Aseptic rota.
• Set up validation processes for any new projects.
• Participate in the development, implementation and monitoring of aseptic pharmacy practice standards, guidelines, protocols, policies and QA SOPs.
• Provide input to ad hoc initiatives and projects as required.
• To undertake any training necessary for the safe and efficient performance of duties.
• To deliver training to other teams within aseptics where appropriate (e.g. GMP, COSHH)
• To participate in the supervision, training and mentoring of pharmacy support workers, pre-registration trainee pharmacy technicians, pre-registration pharmacists and trainees.

Supervises

• Allocated pharmacy staff

Professional / Clinical responsibilities

• Maintain an active and compliant programme of CPD in accordance with hospital guidelines or relevant professional registration body.
• Work with relevant pharmacy staff in managing stock.
• Any other duties commensurate with the role or at the request of the Pharmacy Director and/or Pharmacy Operations Manager.

Education/Qualifications

• Pharmacy Technician registered with General Pharmaceutical Council (GPhC)
• Further training or qualifications in QA/QC
• Current certified GCP training
• Evidence of on-going professional development
• NVQ level 3/BTEC in Pharmaceutical Sciences or equivalent OR ‘A’ level (or equivalent) science or maths qualification(s)
• GCSEs (or equivalent) in Maths and English

Competencies (Complexity of Work):

• Ability to produce clear, concise and well-articulated presentations
• Ability to undertake analysis of large or complex datasets
• Ability to critically analyse complex and difficult situations and apply problem-solving skills
• Critical thinking skills, decisive judgment and the ability to work with minimal supervision
• Ability to work in a pressurized environment and take appropriate action
• Experience analysing large or complex data sets and of using extraction tools
• Excellent analytical, verbal and written communication skills
• Reasonable understanding of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)