Job summary
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.
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.
Job description
Job responsibilities
Quality Assurance
- Assist in day-to-day management of the Quality Management System (QMS), including:
o Change Control
o Deviations
o CAPAs (Corrective and Preventative Actions)
o Self-inspections (Internal Audits)
o Customer Complaints
o 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 including the use of Risk Management Principles and the use of Root Cause Analysis tools.
- Ensure correct application of CAPAs from creation, execution and close out. This includes management of target dates and assessment of extensions.
- Conducts self-inspection audits as per the defined schedule
- Facilitates the assessment and investigation of complex Customer Complaints (particularly relating to product quality) including the use of Risk Management Principles and the use of 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 the completion of all relevant documentation. This includes the conducting of a mock recall on an annual basis. Any identified deficiencies and/or improvements to be captured as part of the QMS.
- Writes and reviews standard operating procedures (SOPs) and training manuals within QA and throughout HPS.
- Assist in managing documentation within the QMS, ensuring compliance with document control procedures.
- Ensuring 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. This includes 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:
o Change Control
o Deviations and investigations
o CAPAs
- Owner of relevant Standard Operating Procedures (SOPs) and responsible for their accuracy, review, update, and implementation ensuring compliance 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.
- Ensures that the data integrity requirements for cGxP are complied with during all aspects of work.
Health, Safety and Environment - Ensures that 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 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 a working competence in all areas of responsibility and to exercise the knowledge and skill that can be reasonably 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 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.
- Attend all mandatory training.
- Participate in appraisal at least annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Comply with all Trust policies, procedures, and protocols.
- Carry out duties with due regard to the Trusts Equal Opportunity Policy.
- Seek advice and support from Line Manager whenever necessary.
- Maintain professional conduct always including appearance.
- Exhibit the values and behaviours expected by the Trust as part of One Culture of Care
Job description
Job responsibilities
Quality Assurance
- Assist in day-to-day management of the Quality Management System (QMS), including:
o Change Control
o Deviations
o CAPAs (Corrective and Preventative Actions)
o Self-inspections (Internal Audits)
o Customer Complaints
o 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 including the use of Risk Management Principles and the use of Root Cause Analysis tools.
- Ensure correct application of CAPAs from creation, execution and close out. This includes management of target dates and assessment of extensions.
- Conducts self-inspection audits as per the defined schedule
- Facilitates the assessment and investigation of complex Customer Complaints (particularly relating to product quality) including the use of Risk Management Principles and the use of 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 the completion of all relevant documentation. This includes the conducting of a mock recall on an annual basis. Any identified deficiencies and/or improvements to be captured as part of the QMS.
- Writes and reviews standard operating procedures (SOPs) and training manuals within QA and throughout HPS.
- Assist in managing documentation within the QMS, ensuring compliance with document control procedures.
- Ensuring 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. This includes 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:
o Change Control
o Deviations and investigations
o CAPAs
- Owner of relevant Standard Operating Procedures (SOPs) and responsible for their accuracy, review, update, and implementation ensuring compliance 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.
- Ensures that the data integrity requirements for cGxP are complied with during all aspects of work.
Health, Safety and Environment - Ensures that 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 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 a working competence in all areas of responsibility and to exercise the knowledge and skill that can be reasonably 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 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.
- Attend all mandatory training.
- Participate in appraisal at least annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Comply with all Trust policies, procedures, and protocols.
- Carry out duties with due regard to the Trusts Equal Opportunity Policy.
- Seek advice and support from Line Manager whenever necessary.
- Maintain professional conduct always including appearance.
- Exhibit the values and behaviours expected by the Trust as part of One Culture of Care
Person Specification
Qualifications/Training
Essential
- Science degree or equivalent level of knowledge in Pharmaceutical Quality Assurance
- Specific training in QMS processes
- Specific training in GMP
Knowledge, Experience and Expertise
Essential
- 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 of dealing with confidential, sensitive (personally and commercial) information with tact and sensitivity.
- Experience of supporting / leading quality and service improvement projects
- Previous experience of 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.
- Able to use own initiative, prioritize workload and pay meticulous attention to detail
Desirable
- Experience of preparation for audits from competent authorities
- Analytical skills to identify themes and trends in data
Communication and Relationships
Essential
- Excellent communication in various forms (oral, written, digital)
- 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
Person Specification
Qualifications/Training
Essential
- Science degree or equivalent level of knowledge in Pharmaceutical Quality Assurance
- Specific training in QMS processes
- Specific training in GMP
Knowledge, Experience and Expertise
Essential
- 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 of dealing with confidential, sensitive (personally and commercial) information with tact and sensitivity.
- Experience of supporting / leading quality and service improvement projects
- Previous experience of 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.
- Able to use own initiative, prioritize workload and pay meticulous attention to detail
Desirable
- Experience of preparation for audits from competent authorities
- Analytical skills to identify themes and trends in data
Communication and Relationships
Essential
- Excellent communication in various forms (oral, written, digital)
- 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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Calderdale and Huddersfield NHS Foundation Trust
Address
Huddersfield Pharmacy Specials
School Street West, Lindley
Huddersfield
HD33ET
Employer's website
https://www.cht.nhs.uk (Opens in a new tab)
