Technical Services Quality Systems Officer

Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.

Job overview

We are pleased to announce a vacancy in search of a Technical Services Quality Systems Officer to work within the aseptic units at Guy's and St Thomas' Aseptic Units for a 12 month secondment. This is a new and innovative role within aseptic units where you will undertake the completion of quality system documents and work closely with production and QA teams to ensure the quality system is maintained in a state of control. You will be involved in the investigation of deviations and errors, undertaking risk and impact assessments and developing actions to correct and prevent these events. You will be part of a team completing these documents and ensure target dates are met. In addition, you will have a key part to play in change management and the introduction of new products, ATMPs and clinical trials.

Main duties of the job

• Provide quality and technical supervision to the GMP manufacturing and aseptic preparation units.
• Complete quality system documents independently and present these to unit managers for approval within the agreed time frames.
• Deliver training on quality system completion.
• Complete new product requests for standard and trial products.
• Support the identification, recording, trending and analysis of in process errors.
• Raise and complete radar reports as required.
• Complete change management documents, present changes at Change Review Board and ensure changes are reviewed and completed within agreed timelines.
• Review audit findings and develop action plans.
• Report progress on audit actions against target completion date.
• Undertake release of unlicensed and prepared medicines according to regulatory and legal requirements.
• Deputise for QA specialist in their absence.

Working for our organisation

Guy's & St Thomas' Technical Services has one of the country's largest manufacturing facilities, split across a number of sites and involves around 140 staff working in licensed manufacturing and named patient dispensing areas. Services include aseptic preparation of CIVAS and chemotherapy, sterile and non-sterile manufacturing, clinical trials, quality control and quality assurance. There is a wide range of expertise throughout the department and many opportunities to learn and develop from technical experts. We have cultivated a culture that prioritises quality and patient safety.

Detailed job description and main responsibilities

Please see job description/person specification for full details on the role and main responsibilities.

Person specification

Experience

• Previous assessable experience of work in an area of pharmaceutical manufacturing unit at a supervisor level.
• Previous assessable experience in staff training and assessment.
• Previous experience of the investigation, risk and impact assessment of deviations and errors and development of corrective and preventative actions.
• Previous experience of change management.
• Experience of aseptic preparation of CIVAS, Chemotherapy, TPN.
• Previous experience of audit.

Knowledge/Qualifications

• Undergraduate or postgraduate Masters degree in a Science related discipline OR Post graduate technical services qualification or equivalent demonstrated portfolio of experience and short courses.

Skills

• Practical knowledge of GMP, QA and all current relevant regulations.
• Ability to organise own time and the time of others.
• Ability to undertake the day to day management, motivation and appraisal of staff.

Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitably according to their needs. We are actively committed to ensuring that no one who applies for a job, works or studies at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity, gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.