Quality Assurance Officer

Quality Assurance Officer The closing date is 06 December 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) The role requires the promotion of cGxP to maintain and develop 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. Job responsibilities Assist in day‑to‑day management of the QMS, including change control, deviations, CAPAs, self‑inspections, customer complaints, and regulatory audits. Facilitate the evaluation and implementation of complex changes managed either via the QMS or projects. Facilitate the assessment and investigation of complex deviations, applying risk management principles and root cause analysis tools. Ensure correct application of CAPAs from creation to close‑out, managing target dates and extensions. Conduct self‑inspection audits as per the defined schedule. Investigate customer complaints using risk‑management and root cause analysis tools. Assist in supplier qualification activities, documentation reviews, and audit coordination. Manage the product recall process, including mock recalls and documenting improvements in 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, supporting induction and refresher training. Support data collection and compilation for Product Quality Reviews (PQRs). Support projects within HPS to ensure regulatory compliance. Lead and deliver minor projects related to QA and associated activities. Ensure all operations within HPS align with cGxP for manufacture and distribution of medicinal products, proposing changes to other departments' processes and policies. Act as ambassador and driver for quality culture throughout HPS. Own relevant SOPs, ensure their accuracy, review, and implementation, and maintain compliance with the latest regulatory expectations. Follow defined SOPs for all work aspects and 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 work aspects. Adhere to Health and Safety and COSHH regulations relating to QA activities. Perform manual handling of equipment, parts, and materials in accordance with good practice. Identify and implement continuous improvement of systems, processes, and equipment, considering advances in technology and best practice. Provide basic clinical technical service indirectly to patients in manufacturing and delivery of medicines. Maintain working competence in all areas of responsibility and exercise required knowledge and skill. Operate professionally and impartially, declaring and avoiding conflicts of interest. Support recruitment of team members. Participate in regular supervision, mandatory training, and annual appraisals, and comply with all Trust policies. Carry out duties with due regard to the Trust's Equal Opportunity Policy and uphold the Trust's values and behaviours. 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. That is why we are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role. Person Specification Qualifications / Training Science degree or equivalent level of 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 of using risk management and investigative tools Experience of performing internal audits Experience of working to deadlines and managing requests Experience dealing with confidential, sensitive information with tact and sensitivity Experience of supporting / leading quality and service improvement projects Previous experience working with controlled documents within a quality system (cGMP, ISO9000 etc.) Able to write routine letters and reports Computer literacy including working knowledge of Microsoft Word, Excel, PowerPoint, Adobe Acrobat, Outlook and Teams Ability to use own initiative, prioritize workload and pay meticulous attention to detail Experience of preparation 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 both internally and externally, and at various levels of seniority Good persuasive and negotiation skills, able 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 (formerly known as CRB) to check for any previous criminal convictions. Calderdale and Huddersfield NHS Foundation Trust #J-18808-Ljbffr