Quality Assurance Officer

NHS; Huddersfield; On-site; GBP 30,000 - 42,000; Full time

Job summary

A regional healthcare provider in Huddersfield is seeking a Quality Assurance Officer to support compliance with Good Manufacturing Practice. You will assist in the management of the Quality Management System, ensuring regulatory requirements are met. The ideal candidate will have a science degree and extensive experience in quality management. Join us to drive a culture of quality and continuous improvement within the organization.

Qualifications

• Extensive experience in using and developing QMS.
• Comprehensive knowledge of pharmaceutical regulation and GxPs.
• Specific training in QMS processes and GMP.

Responsibilities

• Assist in day-to-day management of the Quality Management System (QMS).
• Ensure compliance with GMP, GDP, GCP, and regulatory requirements.
• Write, review, and manage SOPs, training materials, and controlled documents.

Skills

Quality Management System development

Regulatory compliance

Risk management

Internal audit experience

Strong communication skills

Education

Science degree or equivalent knowledge in Pharmaceutical Quality Assurance

Tools

Word

Excel

PowerPoint

Adobe Acrobat

Teams

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 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 cGxP to develop a culture of quality within the division.

Responsibilities

• Assist in day-to-day management of 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
• Facilitate evaluation and implementation of complex changes managed via the QMS or Projects
• Facilitate assessment and investigation of complex deviations using Risk Management Principles and Root Cause Analysis tools
• Ensure correct application of CAPAs with management of target dates and extensions
• Conduct self-inspection audits and participate in external audits
• Assist with supplier qualification activities and audit coordination
• Assist in managing the product recall process, including annual mock recalls and documentation improvements
• Write, review and manage SOPs and training materials within QA and throughout HPS
• Ensure documentation is controlled and review dates are complied with
• Support external audits by regulatory bodies and customers, including preparation and follow-up
• Contribute to cGxP training, including induction and refresher training
• Support data collection for Product Quality Reviews (PQRs) to meet regulatory and customer expectations

Projects

• Support projects within HPS to ensure regulatory compliance
• Lead and deliver minor QA-related projects

Quality and Compliance

• Ensure operations within HPS align with cGxP expectations for manufacture and distribution of medicinal products
• Act as an ambassador and driver for quality culture throughout HPS
• Operate within the QMS including Change Control, Deviations and investigations, CAPAs
• Own and maintain relevant SOPs, ensuring accuracy and alignment with regulatory requirements
• Maintain records aligned with ALCOA++ principles
• Lead self-inspections and participate in inspections and external audits
• Ensure data integrity for cGxP across all activities

Health, Safety and Environment

• Ensure compliance with Health, Safety and COSHH regulations relating to QA activities
• Manual handling of equipment, parts and materials following good practice

Continuous Improvement

• Identify and implement continuous improvements to systems, processes and equipment, considering technology advances and best practice

Clinical Duties

• This role provides a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines

Professional Duties

• Maintain competence and exercise knowledge and skills expected for the role
• Operate professionally and impartially
• Declare and avoid conflicts of interest

Managerial and Financial Duties

• Support recruitment of team members
• Support installation, repair and maintenance of QA equipment and systems

Managing Self

• Participate in supervision and mandatory training
• Engage in annual appraisal and development planning
• Comply with Trust policies and Equal Opportunity Policy
• Seek guidance from Line Manager as needed
• Maintain professional conduct and embody One Culture of Care

Qualifications and Training

Essential

• 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 meeting deadlines and managing requests
• Experience handling confidential information with tact
• 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: Word, Excel, PowerPoint, Adobe Acrobat, Outlook, Teams

Desirable

• Experience preparing for audits from competent authorities
• Analytical skills to identify themes and trends in data

Communication and Relationships

• Excellent communication (oral, written, digital) and interpersonal skills
• Ability to engage with stakeholders at various levels
• Good persuasive and negotiation skills

Disclosures and Sponsorship

• Disclosure and Barring Service (DBS) check required; post may require disclosure submission
• Applications from job seekers needing Skilled Worker sponsorship are welcome

Employer details

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield Pharmacy Specials, School Street West, Lindley, Huddersfield, HD33ET

Employer's website: https://www.cht.nhs.uk