Quality Assurance Officer

NHS; London; Hybrid; GBP 31,000 - 44,000; Full time

Job description

The Quality & Regulatory (Q&R) team is dedicated and specialised to ensuring the highest standards of safety and compliance at UKHSA for VCD and its end users. Our team plays a pivotal role in maintaining the quality and integrity of our medicinal products and processes, ensuring that we meet all regulatory requirements and deliver safe, effective medicinal products to our customers.

The wider Directorate is pivotal to UKHSA's mission, overseeing the comprehensive delivery of commercial, contract management, and business development functions. It manages a vast commercial portfolio, ensuring the agency has the resources to address health security threats. The directorate leads the procurement, storage, and distribution of vaccines and countermeasures for national immunisation and emergency response programmes. It fosters industry partnerships, drives strategic market engagement, and builds supply chain resilience. Additionally, the team is responsible for investment governance, dispute management, and building commercial capabilities. They also develop and execute strategies for income generation, leveraging UKHSA's expertise and facilities to secure funding and commercial opportunities.

The QA Officer will play a key role in the Quality & Regulatory Team by providing core business support. The role will be responsible for ensuring the effective business administration of the Quality & Regulatory team's work.

Main duties of the job

• Regulatory Compliance Assistance: Support the team in ensuring that all activities related to vaccine distribution adhere to regulatory requirements and standards. This includes helping to prepare documentation for regulatory submissions and assisting with regulatory inspections and audits.
• Quality Documentation Management: Assist in managing and maintaining quality-related documentation, such as standard operating procedures, quality manuals, and records of quality control activities. Ensure that documents are up-to-date and compliant with regulatory requirements.
• Support in Quality Monitoring: Help monitor, and track quality metrics and performance indicators related to vaccine distribution. Assist in collecting and analysing data to identify trends, potential issues, and areas for improvement in quality assurance practices.
• Coordination and Communication: Facilitate communication and coordination between quality assurance, regulatory teams, and other departments. Assist in organising meetings, preparing reports, and ensuring that all relevant stakeholders are informed about quality and regulatory matters.
• Identify, discuss and action own professional performance and training / development needs with your line manager through appraisal / individual development plan. Attending internal / external training events.
• To participate in all mandatory training as required, i.e. fire safety, information governance and all other mandatory training.

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 responsibilities

The post holder will be in a cross-cutting role based around the pharmaceutical supply chain and will be expected to engage with a wide range of stakeholders from global pharmaceutical suppliers to our own storage and national distribution provider. The role will involve a reasonable amount of problem-solving and working on Quality Management Systems, and will need attention to detail, as well as delivering at speed.

• Experience working in Quality Assurance within the Pharmaceutical or similar sector
• Have high attention to detail and accuracy
• Ability to interpret and trend quality data
• Good verbal and written communication skills with the ability to defend and explain complicated ideas.
• Ability to work collaboratively as part of a team
• An understanding of and commitment to equality of opportunity and good working relationships.
• Knowledge and experience in Pharmaceutical Quality Management Systems (PQMS)

Selection Process Details

Please note you will not be able to upload your CV. You must complete the application form in as much detail as possible. Please do not email us your CV.

Stage 1: Application & Sift

Success profiles

This vacancy is using success profiles and will assess your behaviours, experience and strengths. You will be required to complete an application form. You will be assessed on the above listed 7 essential criteria, and this will be in the form of:

• Application form (Employer/ Activity history section on the application)
• 1000 word Statement of Suitability.

This should outline how your skills, experience, and knowledge, provide evidence of your suitability for the role, with reference to the essential criteria.

The Application form and Statement of Suitability will be marked together.

In the event of a large number of applications we will longlist into 3 piles of:

Meets all essential criteria

Meets some essential criteria

In order to be shortlisted you must meet all essential criteria and some essential criteria.

Shortlisting: In the event of a large number of applications we will shortlist on:

• Experience working in Quality Assurance within the Pharmaceutical or similar sector

If you are successful at this stage, you will progress to interview and assessment.

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) remote interview.

Behaviours and Strengths will be tested at interview.

The Behaviours tested during the interview stage will be:

• Seeing the Bigger Picture
• Changing and Improving
• Communicating and Influencing
• Working Together

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Eligibility Criteria

Open to all external applicants (anyone) from outside the Civil Service (including by definition internal applicants).

Location

This role is being offered as hybrid working based at any of our Core HQs. We offer great flexible working opportunities at UKHSA and operate using a hybrid working model where business needs allow. This provides us with greater flexibility about how and where we work, to get the best from our workforce. As a hybrid worker, you will be expected to spend a minimum of 60% of your contractual working hours (approximately 3 days a week pro rata, (averaged over a month) working at one of UKHSA's core HQs (Birmingham, Leeds, Liverpool, and London). Our core HQ offices are modern and newly refurbished with excellent city centre transport links and benefit from co-location with other government departments such as the Department for Health and Social Care (DHSC).

Security Clearance Level Requirement

Successful candidates must pass a disclosure and barring security check.

Successful candidates must meet the security requirements before they can be appointed. The level of security needed is Basic Personnel Security Standard.

Person Specification

Statement of Suitability and Application Form

• Statement of Suitability and Application Form

Behaviours

• Seeing the Bigger Picture
• Changing and Improving
• Communicating and Influencing
• Working Together

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.

£31,997 to £43,552 a year Per annum, Pro rata

Contract

Permanent

Working pattern

Full-time, Part-time, Job share, Flexible working