Quality Assurance/Quality Control Officer (Microbiology)

Quality Assurance/Quality Control Officer (Microbiology)

East Suffolk and North Essex NHS Foundation Trust

We are looking for a confident and enthusiastic QA/QC Officer (Microbiology) to join our Pharmacy Quality Assurance Department. You will be based at Colchester Hospital; however, you will be required to work across Ipswich Hospital.

You will be expected to support the Pharmacy Quality Assurance team in ensuring that the regulatory requirements and standards set by the Medicines and Healthcare products Regulatory Agency (MHRA) are met for the Manufacturing Specials, Clinical Trials, and Wholesale dealing licenses held by the Trust.

You will be a team player, joining an established department with a multi-disciplinary team. Our team has various professional scientific backgrounds, including different specialties; therefore, we have a wealth of experience to support your learning and development.

Main duties of the job

• Providing support to the Senior QA/QC Specialist, offering GMP support for all preparative and manufacturing activities and giving oversight to the QA/QC Assistant technical officers.
• Undertaking operational activities and technical projects within the microbiology quality control laboratory, inclusive of routine and non-routine testing.
• Support the Environmental Monitoring & Sterility Assurance programs across technical services.

About us

We are ESNEFT and we provide hospital and community health services to almost one million people across east Suffolk and north Essex. Our dedicated staff deliver care from acute hospitals in Colchester and Ipswich, community hospitals, surgeries, community clinics, and in patients' own homes.

We are one of the largest NHS organisations in England, employing more than 12,000 staff.

We pride ourselves on supporting our staff. We offer a wide range of training and development opportunities, as well as flexible working options.

Along with supporting you to achieve your career goals, we offer a generous pension scheme, unsocial hours payments (where applicable), 27 days annual leave on commencement (pro rata), and access to a range of NHS discounts. Our Staff Health and Wellbeing programme offers a variety of services.

Our philosophy is that Time Matters to everyone. Across the Trust, we concentrate on improving the things we do and removing those which cause time delays for our staff and patients.

We are investing in our commitment to Time Matters with a partnership with leading electronic patient record (EPR) supplier Epic. This digital transformation will bring what's widely regarded as the world's best EPR system to ESNEFT, transforming life in hospital for staff and patients.

If you are passionate about patient care and want to develop your skills and knowledge, then we want to hear from you.

Job responsibilities

For full details of the responsibilities and duties of this role please see the attached job description.

Person Specification

Experience

• Previous experience of Microbiology pharmaceutical GMP in NHS manufacturing unit or pharmaceutical industry as required by MHRA guidance for specials manufactures for batch release.
• Demonstrated experience of multi-disciplinary working within Quality Assurance.
• Experience in a licensed pharmaceutical microbiological testing laboratory within Quality Assurance.
• Previous experience of Aseptic/sterile manufacturing.

Qualifications

• Degree in Microbiology, Pharmaceutical Science or equivalent science degree/certificate.

Knowledge

• Knowledge of pharmaceutical microbiology laboratory testing requirements.
• Knowledge of cGMP/GLP and Quality Control principles.
• Knowledge of laboratory and production facilities, ability to write, update, and review standard operating procedures.
• Understand the principles of ALCOA plus.
• Knowledge of legislation relating to the manufacture and distribution of human medicines.
• Demonstrated knowledge of COSHH and Health and Safety at work.
• Quality Management systems.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975, and as such, it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer name

East Suffolk and North Essex NHS Foundation Trust