Quality Officer (HEO)

This post is for a Quality Officer in GxP Quality Team based at UKHSA, Porton. The post holder will be part of the Quality Assurance Function and will be part of the independent Quality Assurance support of the GxP regulated test facilities.

The successful candidate should be educated to degree level in a relevant subject or have equivalent experience of working at a similar level in the specialist area. We would expect candidates to have an understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more these regulations.

Location:
UKHSA Porton Down, SP4 0JG

*Please be aware that this role can only be worked from within the UK and not overseas. Relocation expenses are not available.*

The main duties of the role are to assist with the communication and expertise needed to run the quality management system.

The post holder will support the Team in the provision of quality assurance for projects within the GxP Test Facility in compliance with the appropriate regulations, including Good Clinical Practice, Good Laboratory Practice and current Good Manufacturing Practice.

Further duties include assisting in the delivery and maintenance of GxP training, QA documentation control, change control and risk assessment quality processes. The post holder 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.

Working Pattern: Full Time, Part Time, Flexible Working, Homeworking.

Responsibilities section:

• 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.
• 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 materialises with stakeholders to ensure appropriate QA support is provided.
• Liaise with stakeholders to ensure appropriate QA support is provided.
• 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 UKHSA’s 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.

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
• Understanding of the Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice regulations and experience of having worked to one or more these regulations
• Good knowledge and preferably practical familiarity with relevant laboratory techniques and safe working practices.
• Experience of regulatory auditing and interaction with external regulators.
• Clear verbal and written communicator with very good writing and presentation skills; capable of constructing and delivering clear ideas and concepts concisely and accurately for diverse audiences.
• Ability to analyze and interpret complex information, evaluate issues and recommend an appropriate course to line manager.
• 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.
• Able to work flexibility in tight and often changing deadlines in a busy environment and able to solve problems and adjust priorities accordingly. Ability to cope with uncertainly and change.
• Excellent computer literacy skills with good knowledge of MS office and ability to produce accurate documentation and manipulate and present information effectively.

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.

• Learning and development tailored to your role
• An environment with flexible working options
• A culture encouraging inclusion and diversity
• A Civil Service pension with an average employer contribution of 27%

Job contact :

Name :
UKHSA Reed Recruitment
Email :
ukhsa.recruitment@reed.com

Recruitment team

Email :
ukhsa.recruitment@reed.com