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

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 be involved in change management and the introduction of new products and clinical trials.

We are looking for a candidate who ideally has experience in aseptic services and pharmaceutical quality assurance, with a desire to progress in these areas. We are a commissioned centre for gene therapy and you will be part of the team involved in aseptic preparation of licensed and trial gene therapy.

Joining our aseptic services team at Guy's & St Thomas' is an exciting proposition, with significant aseptic estates development planned over the next five years and growing demand for clinical trials, cancer treatments, CIVAS and advanced therapies.

Don't miss out on being part of our dynamic journey forward!

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. To 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 actions 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

About us

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 actively promotes patient safety as a top priority. This ethos is ingrained in our team's values and everyday practices, fostering an environment where every member is committed to upholding the highest standards of care.

The extensive multidisciplinary team (MDT), including consultants, registrars, clinical nurse specialists, specialist clinical and technical pharmacists, clinical research teams and administrative staff work together in a dynamic environment to deliver seamless care to our extensive patient cohort.

Job description

Job responsibilities

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

Person Specification

Experience

Essential

• Previous assessable experience of work in an area of pharmaceutical manufacturing unit at a supervisor level
• Previous assessable experience in staff training and assessment

Desirable

• Experience of aseptic preparation of CIVAS, Chemotherapy, TPN

Knowledge/Qualifications

Essential

• Undergraduate or postgraduate Masters degree in a Science related discipline

Desirable

• Specialist higher degree (Masters) in Technical Services (e.g. Pharmaceutical Technology & Quality Assurance MSc) or working towards

Skills

Essential

• Practical knowledge of GMP, QA and all current relevant regulations
• Ability to organise own time and the time of others
• 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

Desirable

• Previous experience of audit
• Ability to undertake the day to day management, motivation and appraisal of staff

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Guy's Hospital

Great Maze Pond

London

SE1 9RT

Any attachments will be accessible after you click to apply.

196-LIS8837