An exciting opportunity to join Leafio as a Quality Officer and play an important role in shaping the future of our pharmaceutical wholesale operations.

As Leafio continues to grow, we are looking for an experienced and detail-oriented Quality Officer who is passionate about maintaining high standards of quality, compliance and patient safety.

This is an opportunity to be part of a business at a pivotal stage of its journey, helping to establish and develop our quality processes as we build a compliant, efficient and reliable pharmaceutical supply chain.

Working closely with our Responsible Person and wider operational teams, you will play a key role in maintaining our Quality Management System, supporting regulatory compliance and ensuring that the medicines moving through our supply chain meet the highest standards.

We are looking for someone who brings hands-on experience within a regulated pharmaceutical environment, a strong understanding of Good Distribution Practice (GDP) and the confidence to take ownership of quality activities in a fast-paced, evolving business.

If you enjoy working collaboratively, have a keen eye for detail and want to make a meaningful contribution to a growing organisation, this could be a fantastic next step in your career.

What is the job?

We are looking for an experienced Quality Officer to join Leafio at a pivotal stage of our growth. This is a unique opportunity to join an ambitious team as we establish our pharmaceutical wholesale operation and secure the licences required to import, store and distribute medicinal products across the UK.

As part of the Quality team, you will ensure the daily activities are actioned and monitored and meet the highest standards of Good Distribution Practice (GDP), regulatory compliance and product quality.

You will play a critical role in ensuring that all medicinal products received, stored and supplied by Leafio comply with GDP, MHRA requirements (esp Reg 167), internal Quality Management Systems (QMS) standards, and customer expectations.

What will you be doing?

Ensure that Deviations, change controls, risk management and CAPAs are actioned according to their target date of completion

Raise Deviations, change controls, risk managements and CAPAs when needed and support in the investigations where relevant

Maintain and update the QMS (SOPs, policies, forms, logs)

Draft standard operating procedures, distribute for reviewing and finalising the procedures

Manage document control, versioning, training records and archiving

Support preparation of quality management review

Deliver GDP and QMS training to the relevant departments where needed

Support with batch traceability, Certificate of Analysis (CoA) documentation and batch release confirmations/verifications

Support with customers’ complaints and ensure timelines are adhered to

Support the Responsible Person (RP) in maintaining compliance and safeguarding product quality throughout the supply chain.

Actively collaborating with cross-functional teams (e.g. pharmacy, warehouse)

Participating and supporting in audits (internal/external) and inspections where required

Any other tasks deemed necessary by the Responsible Person (RP)

What do you need?

Knowledge of Good Manufacturing (GMP) or Good Distribution Practice (GDP) and the regulatory framework governing pharmaceutical wholesale and distribution

Proven experience working within a GMDP regulated pharmaceutical environment, (ideally supporting wholesale distribution and importation), with more than 2 years experience

Proven experience of dealing with a Quality Management Systems (QMS), including but not limited to Complaints, CAPAs, Deviations risk management, change control, self inspections/internal audits

Proven experience in dealing with unlicensed products (especially in accordance with Regulation 167)

Excellent attention to detail and analytical skills

Strong communication and report-writing ability

Highly organised, able to manage multiple tasks and meet deadlines

Desirable

Experience or exposure to Importation of unlicensed products from outside the EEA