The Royal Surrey Aseptic Services is responsible for the preparation and supply of products such as cytotoxic chemotherapy, with independent Production and Quality Assurance (QA) departments.

We require a microbiology Subject Matter Expert to join the QA team to lead the approach required for the sterility assurance of short shelf sterile products, in accordance with Annex 1 EU GMP.

You will have previous experience working within a microbiology test facility, supporting the manufacture of aseptically prepared products, either within the NHS or within the pharmaceutical / life science industry.

Main duties of the job

You will support microbiology risk assessment, sterility assurance strategy and advise on sources of contamination and sanitisation processes. You will also lead investigations following out of trend environmental monitoring results.

This position supports the Quality release of product to wards and customers.

About us

Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you that you feel valued from your initial interview through your entire tenure.

We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.

The Care Quality Commission (CQC) have given us an overall rating of Outstanding.

Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than �45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.

Although it isn't the Trusts normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.

A video about the Royal Surrey - https://www.youtube.com/watch?v=R96pMboIYdo

Job description

Job responsibilities

The Microbiology Officer acts as the Microbiology Subject Matter Expert within the Quality Assurance department, ensuring that the department is compliant with the regulatory requirements of Annex 1 EU GMP. This position has lead responsibility for the provision of microbiology expertise and as such works autonomously within this specialist area (without supervision).

The Microbiology Officer provides key subject matter expertise to ensure that the Pharmacy Aseptic Unit has the appropriate procedures and policies in place that provide assurance that the Unit manufactures sterile product. This position is key to ensuring there is the appropriate expertise in place to support investigations when microbiological results fall outside of pre-defined acceptance criteria. This subject matter expert is key to ensuring the department is compliant with the regulatory requirements of Annex 1 EU GMP.

Provision of Microbiological Subject Matter Expertise, particularly with respect to sources of contamination and disinfection programmes.

Management of all aspects of the environmental monitoring programme, including staff, microbiological media, test equipment, contractors, standard operational procedures and GMP records.

Leading investigations required as a result of environmental monitoring results outside of pre-define acceptance criteria

Training of staff at all levels within the Pharmacy Aseptic Unit on sources of contamination and microbiological control

Responsible for independent release of aseptically prepared products to wards and customers, on behalf of the Head of Quality

Ensuring that the unit is compliant with the requirements of EU GMP Annex 1

Deputise for Lead Technician (QA)

All of the above responsibilities involve written and verbal communication of highly complex and confidential information.

Person Specification

Qualifications

Essential

• Tertiary education to include Microbiology or Life Science qualification to degree level, or equivalent.

Knowledge

Essential

• Experience of the application of the regulatory requirements of Annex 1 EU GMP for Quality Control testing of sterile manufacturing environments.
• Previous experience of working within a QA department following national guidance and legal requirements relating to Aseptic Services and Quality Assurance.
• Significant experience of working within a microbiology / quality assurance department within the EU GMP regulatory environment.
• Previous experience of generating microbiological reports and conducting trend analysis relating to environmental excursions.
• Previous experience of working at supervisory and management level.
• Previous experience of conducting investigations, and determining root causes and implementing Corrective and preventative actions.
• Previous experience of generating and implementing change controls within an aseptic environment.
• A proven knowledge of cleanroom contamination sources and the disinfectant process.

Desirable

• Proven experience of releasing medicines under a specials manufacturing licence.
• Practical experience managing pharmaceutical quality systems
• Previous experience of internal and external audits.

Employer details

Employer name

Royal Surrey NHS Foundation Trust

Address

Royal Surrey Hospital

Guildford

GU2 7XX

Any attachments will be accessible after you click to apply.

384-JH-EMF17035-B6