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