Quality Assurance Officer

Montu UK; Winnersh; Hybrid; GBP 52,000 - 70,000; Full time

Benefits offered by this job

25 days holiday

Pension matching 5%

Private healthcare scheme

Work-from-home options

Cycle-to-work scheme

Enhanced parental leave

Job summary

Leafio is building a robust pharmaceutical wholesale operation in the UK. We are seeking an experienced Quality Officer to ensure GDP, MHRA regulatory compliance, and product quality across receipt, storage and distribution of medicinal products.

You will drive CAPAs, maintain the QMS, draft SOPs, and support audits and inspections, collaborating with cross-functional teams to safeguard product quality throughout the supply chain.

Qualifications

• Knowledge of GMP or GDP and the regulatory framework governing pharmaceutical wholesale and distribution.
• Experience in a GMDP regulated pharmaceutical environment, ideally supporting wholesale distribution and importation, with 2+ years experience.
• Experience with QMS modules (Complaints, CAPAs, Deviations, risk management, change control, audits).
• Experience handling unlicensed products per Regulation 167.
• Excellent attention to detail and analytical skills.

Responsibilities

• Ensure Deviations, change controls, risk management and CAPAs are actioned by target dates.
• Raise Deviations, change controls and CAPAs and support investigations.
• Maintain and update the QMS (SOPs, policies, forms, logs).
• Draft SOPs and manage distribution for reviews and finalisation.
• Manage document control, versioning, training records and archiving.
• Support preparation of quality management reviews and audits.
• Deliver GDP and QMS training to relevant departments.
• Support batch traceability, CoA documentation and batch release verifications.

Skills

GDP/GMP knowledge

Regulatory compliance

QMS/Deviations/ CAPAs

Attention to detail

Audit & inspection support

Tools

ERP system

Job description

What is the job?

We're 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're 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.