Quality Officer

3 weeks ago

Salisbury, United Kingdom UK Health Security Agency Full time

We have an exciting opportunity for a Quality Officer (HEO) on a Fixed-Term appointment (with the possibility of extension) within GxP Quality Team supporting the regulatory work carried out by the Research department at UKHSA Porton.

Additional requirements are excellent communication skills, flexibility, teamwork, proactive responsibility and working to tight and changeable deadlines.

Appropriate training and personal professional development will be positively encouraged.

**Duties of the role includes**:
1. To undertake audits in support of Test Facility/ Quality Control laboratories performing regulated clinical (GCP) and non-clinical (GLP studies and (GMP) Batch Release/ QC tests for internal and external customers.
2. To undertake reviews/ audits of GxP documentation, computer systems, studies (including critical phases and data packages),
supporting areas and critical suppliers of goods and services, as required by the Internal Audit Schedule.
3. To provide support in preparation for, during and after any regulatory or customer audits/ inspections.
4. To liaise with stakeholders, e.g. laboratory managers, customers to ensure appropriate QA support is provided.
5. To provide compliance support and training to staff in and supporting work in the GxP Test Facility.
6. To assist with the review and closure of audit, non-conformances and CAPA reports and related investigations (including root cause
analysis).
7. To assist in the running of the GxP Quality Management Systems.
8. To provide verbal and written updates/ reports on activities to the Senior Management (Quality and Test Facility) in line with overall
responsibilities.
9. To undertake relevant training required for the role.
10. To perform any other duties required by the Line manager.

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.

The Research and Evaluation department based at Porton has approximately 300 staff, performing a range of research activities, including high containment level work. The department’s work covers a broad range of projects involving the development and evaluation of interventions into a range of infectious diseases e.g. SARS-CoV-2, TB, meningitis, anthrax and plague.

The department has also a test facility performing regulated studies in compliance with GLP, GCP and GMP.

Please refer to the job description for full details of the main responsibilities
1. This vacancy is usingSuccess Profilesand will assess your Behaviours/ Strengths/ Experience/ Technical skills.

This should outline how you consider your skills, experience and achievements, and provide evidence of your suitability for the role, with particular reference to the essential criteria outlined.

**STAGE 1 - APPLICATION & SIFT**:
If you are successful at this stage, you will progress to interview.

STAGE 2 - INTERVIEW

All applicants that progress to interview will be assessed on a blended interview against a mixture of Behaviours, Skills and Strength elements of Success Profiles.

**The Behaviours tested during the interview stage will be**:

- Seeing the Big Picture
- Changing and Improving
- Making Effective Decisions
- Managing a Quality Service

The Technical skills tested during the interview stage will be based on:

- Ability to perform & report findings from quality audits of laboratories, data and study reports.
- Knowledge of investigating and managing non-conformances and CAPA.
- Ability to provide face-to-face training as classroom sessions or workshops
- Knowledge and understanding of working to GxP regulations

**Eligibility Criteria Text**:
Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants).

New entrants to the Civil Service are expected to start on the minimum of the pay band.

Either case is determined by whichever is the highest. For further details please refer to the Information Sheet
- Starting Salaries & Benefits attachment.

**Security Clearance Level Requirement**:
**Flexible Working**:
UKHSA offers hybrid working for its employees - this means that whilst the role will be based in one of our UKHSA offices, there will be opportunities for an element of working from home. The balance between home and workplace working is to be agreed with the line manager, determined primarily by business need and in line with departmental policy. Some business travel will be required to other UKHSA offices. Business travel between base location and any other UKHSA offices will be covered under the UKHSA Travel and Expenses policy. Please be aware that this role can only be worked in the UK and not overseas. Relocation expenses are not available.

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