Quality Assurance Officer | Calderdale and Huddersfield NHS Foundation Trust

Calderdale & Huddersfield NHS Foundation Trust; Huddersfield; On-site; GBP 30,000 - 40,000; Full time

Job summary

A prominent healthcare organization in Huddersfield is seeking a Quality Assurance specialist to manage and support the Quality Management System. This role involves ensuring compliance with regulatory standards in pharmaceutical manufacturing and distribution, alongside promoting a strong quality culture. Candidates should have a relevant educational background and experience in quality assurance practices. The position offers opportunities for continuous improvement and professional development.

Qualifications

• Experience with GMP, GDP, GCP, and other cGxP guidelines.
• Ability to write and manage SOPs and controlled documents.
• Skills in internal audits and corrective actions.

Responsibilities

• Support and maintain the Quality Management System (QMS).
• Conduct self-inspection audits and manage documentation.
• Assist with supplier qualification and product recalls.

Skills

Quality Management System (QMS) management

Regulatory compliance

Auditing skills

Risk Management Principles

Strong communication skills

Education

Relevant educational background in Quality Assurance or Pharmacy

Tools

Quality management software

Job description

Overview

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 involves 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 supports the QA Lead in maintaining the QMS at Huddersfield Pharmacy Specials (HPS) and promotes cGxP to develop a culture of quality within the division.

• 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 CHFT

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. That is why we are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role.

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, Regulatory Audits
• Facilitates the evaluation and implementation of complex changes managed either via the QMS (Change Control) or via Projects
• Facilitates the assessment and investigation of complex deviations using Risk Management Principles and Root Cause Analysis tools
• Ensure correct application of CAPAs from creation, execution and close out, including management of target dates and assessment of extensions
• Conducts self-inspection audits as per the defined schedule
• Facilitates assessment and investigation of complex Customer Complaints related 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 relevant documentation, including conducting a mock recall annually; capture deficiencies and improvements as part of the QMS
• Write and review SOPs and training manuals within QA and throughout HPS
• Assist in managing documentation within the QMS, ensuring compliance with document control procedures
• Ensure all documents are controlled as per procedures and review dates are complied with
• Support external audits by regulatory bodies and customers, assisting with preparation, coordination, and follow-up actions
• Contribute to cGxP training activities, including supporting induction and refresher training
• Support improvement initiatives
• Support data collection and compilation for Product Quality Reviews (PQRs) to ensure compliance with 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, CAPAs
• Own relevant Standard Operating Procedures (SOPs) and be responsible for their accuracy, review, update, and implementation in line with latest regulatory expectations
• Follow defined SOPs relating to all aspects of work
• Maintain accurate records aligned with ALCOA++ principles
• Lead self-inspections and participate in inspections and external audits
• Ensure data integrity requirements for cGxP are complied with during all aspects of 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, taking into account advances in technology and best practice. Note continuous improvement could be related to quality, efficiency, customer satisfaction, culture, or cost

Clinical and Professional Duties

• This role provides a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines
• Maintain a working competence in all areas of responsibility and exercise the knowledge and skill expected based on the role and any relevant qualifications
• Operate professionally and impartially
• Declare and avoid any potential conflicts of interest created by the post

Managerial, Financial and Personal Development

• Support in the recruitment of team members
• Support in the installation, repair and maintenance of QA equipment and systems
• Participate in regular supervision and mandatory training
• Participate in annual appraisal and develop your development plan with your Line Manager
• Comply with all Trust policies, procedures, and protocols
• Carry out duties with due regard to the Trust’s Equal Opportunity Policy
• Seek advice and support from Line Manager when necessary
• Maintain professional conduct and embody the values and behaviours of the Trust’s One Culture of Care

This advert closes on Sunday 5 Oct 2025