Job summary
The candidate will be working in the Quality Control Laboratory based within the Pharmacy Production Unit at the Royal Victoria Infirmary. The role involves a mix of traditional quality control laboratory techniques and also supporting the Pharmaceutical quality system such as writing QC worksheets, SOPs and change controls.
The laboratory equipment includes HPLC, FTIR, auto titrators, pH meter, conductivity meter, refractometer, melting point etc. Test methods are used to support product testing for release for patient use and stability studies to support expiry allocation of current products and also allocate expiry's for new products.
- Interview Date Wednesday 15 October 2025
- 37 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
NO AGENCIES PLEASE
Main duties of the job
- Liaises with Pharmacy Production personnel e.g. Operations Manager, production pharmacists, Team Leaders and Specialist Production Technicians also dispensary staff and pharmacy stores staff and on a daily basis.
- Performs checks on ingredients for all laboratory reagents.
- Monitors temperature records to ensure excursions reported immediately to the appropriate member of staff.
- Observing and judging work practices to decide when documentation and procedures require updating.
- Needs to use skills in chemical analysis to develop and validate new methods for product assay and stability as required by local, national and international guidelines.
- Need to interpret the results of any validation work carried out to ensure that they comply with the appropriate protocols and advise the Laboratory Manager accordingly.
- Needs to be able to interpret equipment validation results in order to release equipment into use and produce the appropriate Standard Operating Procedures for final approval by the Laboratory Manager or Trust Quality Controller.
- Needs to be able to interpret and check Suppliers Certificates of Analysis and Certificates of Conformity to ensure compliance with the appropriate Pharmacopoeial Monographs.
- Needs to understand the QC worksheets and related procedures to investigate out of specification results as required by regulatory requirements. To produce hypothesis testing protocols for investigatory work.
About us
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:
- Freeman Hospital
- Royal Victoria Infirmary (RVI)
- Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
- Newcastle Dental Hospital
- Newcastle Fertility Centre
- Northern Centre for Cancer Care, North Cumbria
- Northern Genetics Service
- Cramlington Manor Walks
These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.
We also have offices at Regent Point in Gosforth and community sites.
Please see attached information on what Staff Benefits we have to offer at our Trust under 'Documents to download' or 'Supporting documents'.
For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit:Careers | Newcastle Hospitals | NHS | Newcastle HospitalsandNewcastle Hospitals NHS Foundation Trust
Job description
Job responsibilities
- To undertake the range of laboratory and other duties necessary to ensure the pharmaceutical Quality Control service operates in an efficient, safe and effective manner.
- To operate and maintain a range of equipment to ensure safe and suitable for use. Understanding and following the regulatory requirements for the introduction of new equipment.
- To generate and follow laboratory procedures and worksheets to ensure consistent methodology.
- To undertake the development and validation of stability indicating analytical methods for current and new medicinal products that are manufactured in the Pharmacy Production Unit and for outside companies that we are contracted to perform such work. To plan stability test points and ensure all products are assessed for on-going stability.
- To undertake laboratory investigations in the event of out of specifications in line with current regulatory guidelines. To initiate microbiological investigations in the event of environmental excursions. To generate when required and also be involved in quality control assessment of change controls for the pharmacy production unit and quality control.
- To release Water of Injection in bulk daily following plant and equipment checks.
- The role will lead to the person acting as releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of Specials and to deputise for the Laboratory Manager other quality control duties as required following the completion of an appropriate formal training course that will provide the person with the required body of knowledge to undertake the activities associated with being an authorised releasing officer.
- The role may also lead to training and registration as a QC(MGPS), performing tests on medical gases as required under HTM 02.
Job description
Job responsibilities
- To undertake the range of laboratory and other duties necessary to ensure the pharmaceutical Quality Control service operates in an efficient, safe and effective manner.
- To operate and maintain a range of equipment to ensure safe and suitable for use. Understanding and following the regulatory requirements for the introduction of new equipment.
- To generate and follow laboratory procedures and worksheets to ensure consistent methodology.
- To undertake the development and validation of stability indicating analytical methods for current and new medicinal products that are manufactured in the Pharmacy Production Unit and for outside companies that we are contracted to perform such work. To plan stability test points and ensure all products are assessed for on-going stability.
- To undertake laboratory investigations in the event of out of specifications in line with current regulatory guidelines. To initiate microbiological investigations in the event of environmental excursions. To generate when required and also be involved in quality control assessment of change controls for the pharmacy production unit and quality control.
- To release Water of Injection in bulk daily following plant and equipment checks.
- The role will lead to the person acting as releasing officer for the MHRA MS17163 licence held by Newcastle Specials for the release of Specials and to deputise for the Laboratory Manager other quality control duties as required following the completion of an appropriate formal training course that will provide the person with the required body of knowledge to undertake the activities associated with being an authorised releasing officer.
- The role may also lead to training and registration as a QC(MGPS), performing tests on medical gases as required under HTM 02.
Person Specification
KNOWLEDGE
Essential
- Good working knowledge of organic, inorganic and physical chemistry
- Good knowledge of analytical techniques used in pharmaceutical quality control
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH
Desirable
- Some knowledge of microbiology, preservatives and sterilisation
SKILLS
Essential
- Practical ability to carry out careful and accurate chemical analyses using both traditional and instrumental methods and an awareness of the limitations of different techniques
- Ability to develop new analytical methods
- Good keyboard and general IT skills
- Good communication, interpersonal and organisational skills
- Ability to support the Laboratory Manager in the training of all grades of staff and introducing students into the Quality Control environment
Desirable
- Proficient in use and maintenance of laboratory instruments including FTIR, UV, HPLC
EXPERIENCE
Essential
- Analytical laboratory experience
Desirable
- Experience in pharmaceutical analysis and/or quality control
QUALIFICATIONS
Essential
- Degree or equivalent in a scientific subject e.g. Chemistry or Pharmacy
Desirable
- Postgraduate qualification in analytical chemistry or quality control
- Ability to register with the Royal Society of Chemistry or equivalent
Person Specification
KNOWLEDGE
Essential
- Good working knowledge of organic, inorganic and physical chemistry
- Good knowledge of analytical techniques used in pharmaceutical quality control
- Familiarity with laboratory safety requirements. e.g. HSE, COSHH
Desirable
- Some knowledge of microbiology, preservatives and sterilisation
SKILLS
Essential
- Practical ability to carry out careful and accurate chemical analyses using both traditional and instrumental methods and an awareness of the limitations of different techniques
- Ability to develop new analytical methods
- Good keyboard and general IT skills
- Good communication, interpersonal and organisational skills
- Ability to support the Laboratory Manager in the training of all grades of staff and introducing students into the Quality Control environment
Desirable
- Proficient in use and maintenance of laboratory instruments including FTIR, UV, HPLC
EXPERIENCE
Essential
- Analytical laboratory experience
Desirable
- Experience in pharmaceutical analysis and/or quality control
QUALIFICATIONS
Essential
- Degree or equivalent in a scientific subject e.g. Chemistry or Pharmacy
Desirable
- Postgraduate qualification in analytical chemistry or quality control
- Ability to register with the Royal Society of Chemistry or equivalent
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
