Quality Officer

Job description

Job responsibilities

Responsibilities section:

The job holder will be required to carry out the following responsibilities, activities and duties:

• 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

The duties/responsibilities listed above describe the post as it is at present and is not intended to be exhaustive. The Job holder is expected to accept reasonable alterations and additional tasks of a similar level that may be necessary.

Please see job description attached for full list of responsibilities and duties.

It is important through your application and Statement of Suitability of 1500 words that you give evidence and examples of proven experience of each of the following criteria:

Essential Criteria:

• Educated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
• Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.

• Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.

• Ability to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
• Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
• Ability to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail.

Desirable Criteria:

• Training/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
• Skills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues.

Person Specification

Essential

Essential

• Educated to degree level in a relevant subject (i.e. Biological Sciences) or equivalent level of experience of working at a similar level in specialist area
• Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.
• Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more of these regulations.
• Ability to analyse and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
• Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.
• Ability to plan own work independently and within teams. Can work on own initiative and organize own workload, is self-motivated with a meticulous attention to detail.

Desirable

• Training/experience in Quality Management Systems relevant to this post (e.g. CAPA, change control, risk assessment, document control)
• Skills for communication on complex matters and difficult situations, requiring persuasion and influence. Ability to maintain good working relationships with colleagues

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.

Certificate of Sponsorship

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

UK Health Security Agency

Address

Porton Down, Sailsbury

Manor Farm Road

Porton Down, Sailsbury

SP4 0JG

Employer's website

https://www.gov.uk/government/organisations/uk-health-security-agency (Opens in a new tab)