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 healthcare organization in Huddersfield is seeking a Quality Assurance professional to support compliance with regulations and manage the Quality Management System (QMS). Responsibilities include conducting audits, maintaining documentation, and ensuring adherence to Good Manufacturing and Distribution Practices. Ideal candidates will possess relevant experience in quality management, regulatory compliance, and robust problem-solving skills, contributing to continuous improvement initiatives within the organization.

Qualifications

• Experience with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
• Knowledge of Quality Management Systems (QMS).
• Ability to conduct audits and manage compliance.

Responsibilities

• Support and maintain the QMS, including audits and document control.
• Ensure compliance with GMP, GDP, and regulatory requirements.
• Assist with supplier qualification and regulatory audits.

Skills

Quality management

Regulatory compliance

Problem-solving

Communication

Analytical skills

Education

Relevant degree in pharmacy or related field

Job description

Overview

The purpose of the role is to support the Huddersfield Pharmacy Specials (HPS) Division in ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and Good Control Laboratory Practice (GCLP) – collectively known as cGxP. The role also supports regulatory and licence requirements related to pharmaceutical medicinal products and maintains all aspects of the Quality Management System (QMS) in line with current expectations to support Manufacturing and Distribution Licences.

Responsibilities

• Support and maintain the 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.
• Assist in day‑to‑day management of the QMS, including:
  • Change control
  • Deviations
  • Corrective and preventative actions (CAPAs)
  • Self‑inspections (internal audits)
  • Customer complaints
  • Regulatory audits
• Facilitate the evaluation and implementation of complex changes managed either via the QMS (change control) or via 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, execution and close‑out, including management of target dates and assessment of extensions.
• Conduct self‑inspection audits as per the defined schedule.
• Assistance in the 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 and conducting a mock recall annually.
• Write and review standard operating procedures and training manuals within QA and throughout HPS.
• Assist in managing documentation within the QMS, ensuring compliance with document control procedures.
• 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 and data collection for Product Quality Reviews (PQRs).

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 align with expectations for manufacture and distribution of medicinal products.
• Propose changes to other departments’ processes and policies to align with cGxP.
• Act as ambassador and driver for quality culture throughout HPS.
• Operate within the QMS, including:
  • Change control
  • Deviations and investigations
  • CAPAs
• Own relevant SOPs, ensuring accuracy, review, update and implementation in line with 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 compliance with data integrity requirements for cGxP during all aspects of work.

Health, Safety and Environment

• Ensure compliance with Health and Safety and COSHH regulations related to QA activities.
• Adhere to good practice for manual handling of equipment, parts and materials.

Continuous Improvement

• Identify and implement continuous improvement of systems, processes and equipment, considering advances in technology and best practice.

Clinical Duties

• 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 reasonably expected.
• Operate professionally and impartially.
• Declare and avoid any potential conflicts of interest created by the post.

Managerial Duties

• Support recruitment of team members.

Financial Duties

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

Managing Self

• Participate in regular supervision.
• Attend all mandatory training.
• Participate in annual appraisal, developing and agreeing a personal development plan with the line manager.
• Comply with all Trust policies, procedures and protocols.
• Abide by the Trust’s Equal Opportunity Policy.
• Seek advice and support from the line manager when necessary.
• Maintain professional conduct and appearance.
• Exhibit the values and behaviours expected by the Trust as part of "One Culture of Care".

This advert closes on Saturday 6 Dec 2025.