About this role
Job summary
An opportunity has arisen for a Band 5 Senior Quality Assurance Officer to support the Pharmaceutical Quality System within the Stockton Quality Control Laboratory. The role will contribute to ensuring compliance with Good Manufacturing Practice (GMP) and other regulatory requirements, supporting validation, audit readiness and continuous improvement of quality systems.The post holder will work closely with the Head of Quality Management & Validation and wider laboratory team to maintain inspection readiness, progress audit actions and ensure quality processes are delivered effectively.
Main duties of the job
The post holder will support the implementation and maintenance of the Pharmaceutical Quality System, including management of deviations, CAPA, change control and document control processes.They will contribute to validation activities for equipment, facilities and systems, participate in internal and external audits, and support inspection readiness. The role also includes maintaining training compliance, contributing to KPI reporting and supporting continuous improvement activities across the laboratory.The post holder will work collaboratively across the service, providing advice on quality matters and supporting staff in the application of GMP principles.
About us
The Stockton Quality Control Laboratory is part of the Pharmacy service and plays a key role in supporting safe and compliant healthcare delivery through analytical testing and quality assurance activities.The organisation is committed to maintaining high standards of quality and regulatory compliance, with a strong focus on continuous improvement, patient safety and staff development. The post holder will be part of a multidisciplinary team working to deliver a robust and effective quality system aligned to national standards.
Job description Job responsibilities
The post holder will support the management and maintenance of the Pharmaceutical Quality System in accordance with GMP requirements. This includes handling deviations, CAPA, change control and ensuring quality records are completed accurately and in a timely manner in line with data integrity principles.They will contribute to validation activities, including preparation and execution of protocols and reports for equipment, facilities and computerised systems. The role will involve supporting audit processes through preparation of documentation, participation in inspections and tracking of actions to completion.The post holder will maintain and update controlled documentation, support training compliance through management of training records, and assist in the delivery of GMP training where required. They will contribute to KPI data collection and reporting, highlighting risks or delays where appropriate.Working closely with the Senior QA team, the post holder will support continuous improvement of quality processes, ensure compliance with regulatory standards, and contribute to maintaining inspection readiness at all times.
Person Specification
Knowledge & Skills Essential
Good knowledge of GMP regulations Working knowledge of current pharmaceutical quality management Ability to communicate effectively to a range of professionals with conflicting priorities Computer literate with excellent knowledge of Office package Ability to influence and train others
Desirable
Experience in performing validation activities in a GMP environment
Qualifications & Training Essential
Minimum of 3 years' experience in quality assurance within a GMP-regulated pharmaceutical or healthcare environment
Desirable
degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Engineering or a closely related discipline completion of Pharmaceutical GMP Auditor/Lead Auditor course
Experience Essential
Extensive experience in using and developing quality management systems within a regulated pharmaceutical environment Experience of working in a GMP regulated environment Experience of developing cost effective methods and validating methods Work within a GMP inspected laboratory and working with quality systems
Desirable
Prior exposure to microbiological methods (e.g. plate counts, broth cultures, staining, PCR) and familiarity with relevant instrumentation and quality standards Previous experience of participating in MHRA inspections.
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 North Tees & Hartlepool NHS Foundation Trust
Address University Hospital of North Tees
Hardwick Road
Stockton-on-Tees
TS19 8PE
United Kingdom
Employer's website https://www.nth.nhs.uk/ (Opens in a new tab)