Quality Assurance Officer

NHS; Huddersfield; On-site; GBP 35,000 - 45,000; Full time

Job summary

A healthcare organization in Huddersfield seeks a Quality Assurance professional to support and maintain the Quality Management System (QMS), ensuring compliance with GMP, GDP, and other regulatory requirements. The ideal candidate will have extensive experience in developing QMS and will be responsible for audits, investigations, and promoting a culture of quality. This role offers opportunities for personal development and improvement in service delivery.

Qualifications

• Specific training in QMS processes.
• Specific training in GMP.
• Experience with risk management and investigative tools.

Responsibilities

• Support and maintain the Quality Management System (QMS).
• Ensure compliance with GMP, GDP, GCP, and regulatory requirements.
• Assist with supplier qualification, product recalls, and customer regulatory audits.

Skills

Extensive experience in using and developing QMS

Analytical skills to identify themes and trends

Excellent interpersonal skills

Good persuasive and negotiation skills

Education

Science degree or equivalent in Pharmaceutical Quality Assurance

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Adobe Acrobat

Microsoft Outlook

Microsoft Teams

Job description

Overview

Go back Calderdale and Huddersfield NHS Foundation Trust

The closing date is 28 September 2025

The purpose of the role is to support the Division to ensure compliance with the latest Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP), Good Control Laboratory Practice (GCLP) - collectively known as cGxP. Additionally, the role supports the regulatory and licence requirements relating to pharmaceutical medicinal products. This entails maintaining all aspects of the Quality Management System (QMS) in-line with current expectations to support Manufacturing and Distribution Licences held by the Huddersfield Pharmacy Specials (HPS) Division. The role requires supporting the QA Lead in maintaining the QMS at Huddersfield Pharmacy Specials (HPS) and promoting a culture of quality within the division.

Main duties of the job

• Support and maintain the Quality Management System (QMS), including audits, investigations, CAPAs, and document control.
• Ensure compliance with GMP, GDP, GCP, and regulatory requirements.
• Write, review, and manage SOPs, training materials, and controlled documents.
• Assist with supplier qualification, product recalls, and customer/regulatory audits.
• Promote a strong quality culture and drive continuous improvement across the organisation.

About us

CHFT is an integrated Trust of 6,500+ colleagues providing hospital and community services to patients and communities across Calderdale and Kirklees. We are rated as 'Good' by the Care Quality Commission, are a top performing Trust for Elective Recovery, Emergency and Cancer Care and widely acknowledged as a national digital lead when it comes to caring for people across our local and regional systems.

Our people are at the core of everything we do, hence our commitment to One Culture of Care. Our focus is to care for and support each other in order to provide outstanding compassionate care to our patients. We are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role.

Job responsibilities

Quality Assurance

• Assist in day-to-day management of the Quality Management System (QMS), including Change Control, Deviations, CAPAs (Corrective and Preventative Actions), Self-inspections (Internal Audits), Customer Complaints, and Regulatory Audits.
• Facilitate evaluation and implementation of complex changes managed via the QMS (Change Control) or via Projects.
• Facilitate assessment and investigation of complex deviations using Risk Management Principles and Root Cause Analysis tools.
• Ensure correct application of CAPAs from creation to close-out, including management of target dates and extensions.
• Conduct self-inspection audits as per the defined schedule.
• Facilitate assessment and investigation of complex Customer Complaints (particularly relating to product quality) using Risk Management Principles and Root Cause Analysis tools.
• Assist in day-to-day management of supplier qualification activities, including documentation reviews and audit coordination.
• Assist in managing the product recall process, ensuring completion of all relevant documentation, including conducting a mock recall annually and capturing deficiencies for the QMS.
• Write and review SOPs and training manuals within QA and throughout HPS.
• Manage documentation within the QMS, ensuring compliance with document control procedures and review dates.
• Support external audits by regulatory bodies and customers, assisting with preparation, coordination, and follow-up actions.
• Contribute to cGxP training activities, including induction and refresher training.
• Support data collection and compilation for Product Quality Reviews (PQRs) to ensure regulatory and customer expectations.

Projects

• Support projects within HPS to ensure compliance with regulations.
• Lead and deliver minor projects specifically related to QA and associated activities.

Quality and Compliance

• Ensure all aspects of operations within HPS are aligned with current expectations relating to the manufacture and distribution of medicinal products, including proposing changes to other departments’ processes and policies to align with cGxP.
• Ambassador and driver for quality culture throughout HPS.
• Operate within the QMS including Change Control, Deviations and investigations, and CAPAs.
• Own relevant SOPs and be responsible for their accuracy, review, update, and implementation ensuring compliance with latest regulatory expectations.
• Maintain ALCOA++ data integrity, lead self-inspections, participate in inspections and external audits.
• Ensure data integrity requirements for cGxP are complied with during all work.

Health, Safety and Environment

• Ensure Health and Safety and COSHH regulations relating to QA activities are adhered to.
• Manual Handling of equipment, parts and materials is done in accordance with good practice.

Continuous Improvement

• Identify and implement continuous improvement of systems, processes, and equipment, considering advances in technology and best practice. Note continuous improvement could relate to quality, efficiency, customer satisfaction, culture, or cost.

Clinical Duties

• This role is deemed to provide a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines.

Professional Duties

• Maintain working competence in all areas of responsibility and exercise the knowledge and skill expected based on the role and qualifications.
• Operate professionally and impartially.
• Declare and avoid conflicts of interest related to the post.

Managerial Duties

• Support in the recruitment of team members.

Financial Duties

• Support in the installation, repair and maintenance of QA equipment and systems.

Managing Self

• Participate in regular supervision and mandatory training.
• Participate in annual appraisal and develop your development plan with your Line Manager using the Trust Appraisal process.
• Comply with Trust policies, Equal Opportunity Policy, and other protocols.
• Seek advice from Line Manager when necessary and maintain professional conduct and the values of One Culture of Care.

Person Specification

Qualifications/Training

• Science degree or equivalent knowledge in Pharmaceutical Quality Assurance
• Specific training in QMS processes
• Specific training in GMP

Knowledge, Experience and Expertise

• Extensive experience in using and developing QMS
• Comprehensive knowledge of pharmaceutical regulation and GxPs
• Experience with risk management and investigative tools
• Experience performing internal audits
• Experience working to deadlines and managing requests
• Experience handling confidential information with tact and sensitivity
• Experience supporting/leading quality and service improvement projects
• Experience with controlled documents within a quality system (cGMP, ISO9000 etc)
• Able to write routine letters and reports
• Computer literacy with Microsoft Word, Excel, PowerPoint, Adobe Acrobat, Outlook and Teams
• Able to use own initiative, prioritise workload and pay meticulous attention to detail
• Experience preparing for audits from competent authorities
• Analytical skills to identify themes and trends in data

Communication and Relationships

• Excellent interpersonal skills with the ability to engage with stakeholders at various levels
• Good persuasive and negotiation skills to manage conflicts

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 to check for any previous criminal convictions.

Calderdale and Huddersfield NHS Foundation Trust