Quality Assurance Officer

Job description

**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 - Experience in working with an ERP system - Previous experience working within the medical cannabis sector - Previous experience in releasing products (QC-Quality control) **What we offer:** - Generous Leave: 25 days holiday (rising to 27 after year one and 30 after year three + 8 bank holidays - Pension Matching: Up to 5% employer matching contributions - Private Healthcare Scheme - Flexibility and Wellness: Work-from-home options, cycle-to-work scheme, and more - Growth Opportunities: Collaborate across teams and represent Montu at events, with support to grow your skills and impact - Enhanced Maternity & Paternity Leave **About Us** At Leafio, we’re building a smarter, more resilient pharmaceutical supply chain that gives pharmacies fast and reliable access to the medicines they need, when they need them. By working directly with manufacturers and creating a more efficient wholesale model, we’re improving stock availability, simplifying distribution and helping to make medicines more affordable for patients. Everything we do is focused on creating a supply chain that is responsive, transparent and equipped to better support healthcare providers across the UK. We are an ambitious, fast-growing business with exciting plans for the future. This is an opportunity to make a genuine impact, help shape how we grow and join a team that is modernising pharmaceutical distribution from the ground up.