Job overview

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.

Detailed job description and main 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

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Person specification:

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

Education/Qualifications

Essential

• BSc in Chemistry, Pharmaceutical Science or related scientific discipline.

Desirable

• Membership of the Royal Society of Chemistry

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