JOB SUMMARY

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.
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.

JOB DESCRIPTION

• 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.
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.

NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements

ESSENTIAL ROLE CRITERIA:

• 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)