Job summary
We are looking for a Quality Officer in GxP Quality Assurance Team, part of the Vaccine Development & Evaluation Centre (VDEC). The GxP QA Team provide GCP, GLP and GMP compliance support to the GxP regulated test facilities on the Porton site.
The team are responsible for managing GxP Quality Management Systems such as the internal audit programme, supplier management, training, non-conformances & CAPA, change management, document control, quality risk assessment and hosting external inspections and audits. The role is an interesting and varied role, within a supportive and experienced team.
The successful candidate should hold a degree in a relevant subject (i.e. Biological Sciences) or have equivalent experience of working at a similar level in the specialist area and have a good understanding and experience of working to at least one of the GxP regulations (GCP, GLP or GMP).
Main duties of the job
The main duties of the role are to assist with the communication and expertise needed to run the GxP quality management system. The post holder will support the QA Team in the provision of quality assurance for projects within the GxP Test Facility in compliance with the appropriate regulations, including Good Clinical Practice (GMP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Duties include assisting in the support and delivery of GxP training, document control, change control and risk assessment quality processes. The postholder will be required to undertake assigned audits as part of the GxP internal audit programme, including conducting QA reviews/audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and materials. The role will also support ongoing work to migrate processes from a GxP paper-based to electronic quality management system (eQMS).
About us
We pride ourselves as being an employer of choice, where Everyone Matters promoting equality of opportunity to actively encourage applications from everyone, including groups currently underrepresented in our workforce.
UKHSA ethos is to be an inclusive organisation for all our staff and stakeholders. To create, nurture and sustain an inclusive culture, where differences drive innovative solutions to meet the needs of our workforce and wider communities. We do this through celebrating and protecting differences by removing barriers and promoting equity and equality of opportunity for all.
Please visit our careers site for more information https://gov.uk/ukhsa/careers
Job description
Job responsibilities
The main duties of the role are to assist with the communication and expertise needed to run the quality management system, and include:
- Assist in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes.
- Deliver GxP Training to meet quality, business, and regulatory requirements.
- Liaise with stakeholders to ensure appropriate QA support is provided.
- Undertake assigned audits as part of the GxP internal audit programme including conducting QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and material.
- Contribute to writing key quality documents e.g. Quality Reports, Risk Assessments, Technical Agreements and Standard Operating Procedures etc.
- Undertake the review and approval of non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
- Assist GxP Test Facilities areas, Test Facilities Management, and the Quality Team in preparation for, and during customer audits and regulatory inspections.
- Perform any other duties required by the Line Manager commensurate with grade.
- Undertake work in accordance with the UKHSAs risk management systems, policies and procedures, applicable quality systems (including current GLP, GCP and GMP regulations), H&S Laboratory Precautions Handbook and site-wide UKHSA policies and procedures.
- To fulfil the requirements of UKHSA Values and Behaviours commensurate with grade.
Other
- The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the directorate and your line manager.
- The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation.
- It should be noted that the work of the organisation is of a confidential nature and must not be communicated to other persons except where required for authorised purposes.
For a full list of Essential and Desirable Criteria, please see attached job description
Essential criteria
You will be assessed on the below 4 essential criteria, which have been selected from the Job Description
- A degree in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area.
- Good understanding of the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) regulations and experience of having worked to one or more these regulations.
- Experience of auditing (preferably GxP).
- Training/ experience in Quality Management Systems relevant to this post (e.g. Non-conformance & CAPA, change control, risk assessment, document control).
Selection Process
Stage 1: Application & Sift
You will be required to complete an application form. You will be assessed on the above 4 listed essential criteria, and this will be in the form of
- an Application form (Employer/ Activity history section on the application)
- a 1000 word Statement of Suitability.
This should outline how your skills, behaviours, knowledge, and experience provide evidence of your suitability for the role, with reference to the 4 listed essential criteria.
The CV and Statement of Suitability will be marked together.Shortlisting: In the event of receiving a large number of applications we will shortlist on the following essential criteria:
Good understanding of the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) regulations and experience of having worked to one or more these regulations.Unfortunately, late applications will not be considered
If you are successful at this stage, you will progress to interview.
Please do not exceed 1000 words. We will not consider any words over and above this number. Feedback will not be provided at this stage.
Stage 2: Interview (Success Profiles)
You will be invited to a single face to face interview.
Behaviours, knowledge, and technical experience will be tested at interview.
The Behaviours tested during the interview stage will be:
- Making Effective Decisions
- Communicating and Influencing
- Working Together
- Managing a Quality Service
Interviews dates to be confirmed.
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Location
This role is based at Porton Down- please note hybrid working is not available for this role.
Eligibility Criteria
External: Open to all external applicants (anyone) from outside the Civil Service (including internal applicants).Security Clearance Level Requirement
Successful candidates must pass a disclosure and barring security check.
This role is based at Porton Down. If based at one of our scientific locations you will be required to have a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. In exceptional circumstances UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.
Job description
Job responsibilities
The main duties of the role are to assist with the communication and expertise needed to run the quality management system, and include:
- Assist in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes.
- Deliver GxP Training to meet quality, business, and regulatory requirements.
- Liaise with stakeholders to ensure appropriate QA support is provided.
- Undertake assigned audits as part of the GxP internal audit programme including conducting QA reviews/ audits on study data, study records, GxP laboratories, supporting areas and critical suppliers of services and material.
- Contribute to writing key quality documents e.g. Quality Reports, Risk Assessments, Technical Agreements and Standard Operating Procedures etc.
- Undertake the review and approval of non-conformances, CAPA reports and related investigations, change controls and supplier approval questionnaires.
- Assist GxP Test Facilities areas, Test Facilities Management, and the Quality Team in preparation for, and during customer audits and regulatory inspections.
- Perform any other duties required by the Line Manager commensurate with grade.
- Undertake work in accordance with the UKHSAs risk management systems, policies and procedures, applicable quality systems (including current GLP, GCP and GMP regulations), H&S Laboratory Precautions Handbook and site-wide UKHSA policies and procedures.
- To fulfil the requirements of UKHSA Values and Behaviours commensurate with grade.
Other
- The above is only an outline of the tasks, responsibilities and outcomes required of the role. You will carry out any other duties as may reasonably be required by the directorate and your line manager.
- The job description and person specification may be reviewed on an ongoing basis in accordance with the changing needs of the organisation.
- It should be noted that the work of the organisation is of a confidential nature and must not be communicated to other persons except where required for authorised purposes.
For a full list of Essential and Desirable Criteria, please see attached job description
Essential criteria
You will be assessed on the below 4 essential criteria, which have been selected from the Job Description
- A degree in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area.
- Good understanding of the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) regulations and experience of having worked to one or more these regulations.
- Experience of auditing (preferably GxP).
- Training/ experience in Quality Management Systems relevant to this post (e.g. Non-conformance & CAPA, change control, risk assessment, document control).
Selection Process
Stage 1: Application & Sift
You will be required to complete an application form. You will be assessed on the above 4 listed essential criteria, and this will be in the form of
- an Application form (Employer/ Activity history section on the application)
- a 1000 word Statement of Suitability.
This should outline how your skills, behaviours, knowledge, and experience provide evidence of your suitability for the role, with reference to the 4 listed essential criteria.
The CV and Statement of Suitability will be marked together.Shortlisting: In the event of receiving a large number of applications we will shortlist on the following essential criteria:
Good understanding of the Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Clinical Practice (GCP) regulations and experience of having worked to one or more these regulations.Unfortunately, late applications will not be considered
If you are successful at this stage, you will progress to interview.
Please do not exceed 1000 words. We will not consider any words over and above this number. Feedback will not be provided at this stage.
Stage 2: Interview (Success Profiles)
You will be invited to a single face to face interview.
Behaviours, knowledge, and technical experience will be tested at interview.
The Behaviours tested during the interview stage will be:
- Making Effective Decisions
- Communicating and Influencing
- Working Together
- Managing a Quality Service
Interviews dates to be confirmed.
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Location
This role is based at Porton Down- please note hybrid working is not available for this role.
Eligibility Criteria
External: Open to all external applicants (anyone) from outside the Civil Service (including internal applicants).Security Clearance Level Requirement
Successful candidates must pass a disclosure and barring security check.
This role is based at Porton Down. If based at one of our scientific locations you will be required to have a Counter Terrorism Check security vetting check as a minimum. For meaningful National Security Vetting checks to be carried out individuals need to have lived in the UK for a sufficient period of time. You should normally have been resident in the United Kingdom for the last 3 years as the role requires Counter Terrorism Check (CTC) clearance. In exceptional circumstances UK residency less than the outlined periods may not necessarily bar you from gaining national security vetting and applicants should contact the Vacancy Holder/Recruiting Manager listed in the advert for further advice.
Person Specification
Application form and Statement of Suitability
Essential
- Application form and Statement of Suitability
Behaviours
Essential
- Making effective decisions
- Communicating and influencing
- Working together
- Managing a quality service
Person Specification
Application form and Statement of Suitability
Essential
- Application form and Statement of Suitability
Behaviours
Essential
- Making effective decisions
- Communicating and influencing
- Working together
- Managing a quality service
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).
