About this role
Job summary
The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is a Medicines and Healthcare products Regulatory Agency (MHRA)-Licensed Unit manufacturing a broad portfolio of terminally sterilised and non-sterile Specials (unlicensed) medicines. Additionally, under our MIA(IMP) Licence, the PMU provides clinical trial manufacturing activities through our collaboration with King's Health Partners and other clinical trial organisations.
The Quality Control (QC) Department possesses a broad range of technical and operational capabilities that ensure the quality, safety, and compliance of medicines and pharmaceutical products. The department is equipped to perform analytical testing, method validation and verification and stability studies. Through its expertise in GMP compliance, quality risk management, and regulatory requirements, QC provides assurance that products consistently meet defined quality standards before release for patient use.
As a key department within the PMU, the QC Laboratory supports the wider team by providing timely quality assessments, analytical data, and expert technical advice that inform decision-making across all pharmaceutical manufacturing specialities.
Main duties of the job
The Senior Quality Control Analyst is responsible for the day-to-day delivery of analytical testing activities within the Quality Control Laboratory, ensuring compliance with Good Manufacturing Practice (GMP), Good Control Laboratory Practice (GCLP), MHRA requirements and Trust policies.
The post holder performs testing of raw materials, packaging components, finished products, stability samples and water systems; supports investigations, equipment qualification and validation activities; contributes to maintenance of the Pharmaceutical Quality System (PQS); and provides training and day-to-day supervision of junior staff.
About us
Guy's and St Thomas' NHS Foundation Trust is one of the largest and most respected NHS organisations in the UK, with a strong reputation for clinical excellence, research and innovation. The Trust is part of King's Health Partners, an internationally recognised academic health sciences centre.
Within the Trust, Technical Services plays a vital role in supporting patient care through the manufacture and supply of high-quality unlicensed medicines and clinical trial products. The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is a well-established facility operating to MHRA standards, offering a diverse and rewarding working environment with opportunities to develop expertise in pharmaceutical manufacturing, quality systems and clinical trials.
Staff are supported through structured training, professional development opportunities and a collaborative team culture focused on safety, quality and continuous improvement.
Job description Job responsibilities
This key role responsibilities include
To ensure that the conduct of analytical activities in the Quality Control Laboratory in the PMU meet the requirements of GMP, GCLP, The Health and Safety at Work Act 1974, COSHH Regulations and any other applicable legislation. To undertake Finished product, Raw Material, Containers and Stability testing in line with current specifications, protocols and Pharmacopeial standards. To be fully conversant with HPLC, FTIR, UV spectroscopy, TOC analysis and other physical/chemical testing methods to be able to interpret data and assess the validity of results To support the maintenance of the QC Pharmaceutical Quality System including documenting quality exceptions, investigating OOT/OOS and implementing Corrective & Preventative actions. To support new and existing staff by delivering competency based training on QC processes, equipment and systems. See Job Description for full details
Person Specification
Education/Qualifications Essential
BSc in Chemistry, Pharmaceutical Science or related scientific discipline.
Desirable
Membership of the Royal Society of Chemistry
Previous Experience Essential
A minimum of 3 years' post-graduation experience in a GMP regulated QC laboratory Experience of a range of analytical chemistry techniques (including HPLC, UV, FTIR, dissolution, disintegration) and general wet chemistry testing Experience of Quality Management Systems including risk assessment, deviation reporting and change control Experience of equipment calibration and, management of maintenance schedules
Desirable
Previous experience of working in the pharmaceutical industry. Experience of testing raw materials to pharmacopeial requirements Experience of conducting Root Cause Analysis, OOS/OOT and CAPA management Previous experience of equipment commissioning and qualification Experience of participating in quality audits, including regulatory inspections
Skills / Knowledge / Abilty Essential
Demonstrated understanding of GCLP and GMP guidelines in a manufacturing environment Demonstrated ability to review GMP documentation completed or created by others including testing data, SOP, specifications and protocols. Ability to use GMP compliant computerised laboratory information systems Demonstrated ability to comply with standard operating procedures and to assess other staff's compliance with these procedures.
Desirable
Demonstrated understanding of current regulations governing Specials manufacture and the role of the MHRA Demonstrated ability to interpret analytical data and make appropriate technical judgements Experience of using electronic documentation systems and electronic materials management systems Experience of undertaking COSHH assessments
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.
Certificate of Sponsorship 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).
Employer details Employer name Guy's and St Thomas' NHS Foundation Trust
Address Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Employer's website https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)