Principal QC Analyst - Microbiology

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Main area: Pharmaceutical Microbiology and Chemistry

Grade Band: 6

Contract: Permanent

Hours: Full time - 37.5 hours per week (Able to work in Weekend)

Job ref: 337-NP-8539DG-A

Site: Northwick Park Hospital

Town: Harrow

Salary: per annum inclusive of High Cost Area Supplement

Closing: 15/04/2025 09:00

London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.

Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.

• Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country.
• St Mark’s Hospital: an internationally renowned specialist centre for bowel disease.
• Ealing Hospital: a busy district general hospital providing a range of clinical services.
• Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services.

We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.

Find out more about our Trust and why you should join us#WeAreLNWH

Our vision at London North West University Healthcare NHS Trust is to put “Quality at our HEART”.

We are clear that our vision can only be achieved by our staff, who are our most valuable asset.

Our vision is driven by our HEART values and behaviours which were developed together with our staff.

• H onesty
• A ccountability
• T eamwork

These values describe how we interact with each other and our patients and must underpin everything we do to achieve our vision.

LNWUH is a flexible working friendly organisation. Please speak to us about how we might be able to accommodate a flexible working arrangement.

Job overview

This post is to provide direct support to the Quality Department in the management of the day-to-day aspects of the Quality Control Laboratory to ensure adherence to established quality standards.

The post holder will need the combined skills of project management, data analytical skills and be able to communicate effectively with PTS team members at all levels.

Main duties of the job

Analysis, interpretation and reporting of test results of a wide range of raw materials, packaging materials, intermediates bulk and finished products as required.

• To undertake and supervise stability studies – microbiological and analytical method development and validation of new formulations and existing products.
• Responsible for the establishment, maintenance and review of the documents supporting the Pharmaceutical Quality System (PQS).
• To ensure timely closure of incident logs, deviations, change controls, and CAPAs by carrying out tasks as agreed.
• To carry out laboratory investigation and root cause analysis as needed.
• Comply with data integrity policy and procedure.
• Provision of microbiological trend analysis reports and potential improvements.
• To act as a releasing officer for pre-pack over labelled products manufactured under MHRA ‘Specials’ licence.

Working for our organisation

The Pharmacy Technical Services Department at Northwick Park Hospital offers comprehensive pharmaceutical manufacturing services.

Person specification

Education/Qualifications

• BSc degree in Chemistry, Pharmaceutical Science or relevant scientific discipline.

Knowledge & Experience

• Minimum of 5 years laboratory experience in hospital or industry linked to a manufacturing unit.
• Knowledgeable in different microbiological and laboratory instrumentation techniques.
• Demonstrated ability to identify problems, analyse root cause and propose solutions.
• Experience of working to Pharmacopoeial methods and specifications.
• Knowledge and experience of compliance to MHRA GxP Data Integrity guidance.
• Knowledgeable in environmental monitoring of clean rooms.
• Knowledgeable in microbiological method validation, gram staining and microbiological identification testing.

The Trust is committed to safeguarding and promoting the welfare of children, young people and adults at risk.

Due to the high volumes of applications we receive for certain posts, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications.

Please note the Trust uses identity checking software for verifying the authenticity of identity documents provided by candidates.

As part of our commitment to the Equality and Diversity at LNWUH, we are encouraging applications from BME (Black, Minority Ethnic) candidates.