Quality Control Senior Analyst | Guy's and St Thomas' NHS Foundation Trust

Quality Control Senior Analyst | Guy's and St Thomas' NHS Foundation Trust

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.

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.

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.

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.