Senior Quality Assurance Officer

The role

The Quality Officer will maintain the Quality Management System and support regulatory compliance for pharmaceutical wholesale operations. This role involves managing deviations, change controls, and risk management to ensure medicines meet GDP and MHRA requirements.

What you will do

• Ensure Deviations, change controls, risk management and CAPAs are actioned according to target dates
• Raise Deviations, change controls, risk managements and CAPAs and support investigations
• Maintain and update the QMS including SOPs, policies, forms, and logs
• Draft, distribute, review, and finalise standard operating procedures
• Manage document control, versioning, training records and archiving
• Support preparation of quality management review
• Deliver GDP and QMS training to relevant departments
• Support batch traceability, Certificate of Analysis documentation and batch release confirmations
• Support customers complaints and ensure timelines are adhered to
• Support the Responsible Person in maintaining compliance and safeguarding product quality

Required qualifications

• Knowledge of Good Manufacturing (GMP) or Good Distribution Practice (GDP) and the regulatory framework governing pharmaceutical wholesale and distribution
• More than 2 years experience working within a GMDP regulated pharmaceutical environment
• Proven experience of dealing with a Quality Management Systems (QMS), including Complaints, CAPAs, Deviations risk management, change control, self inspections/internal audits
• Proven experience in dealing with unlicensed products 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

Nice to have

• 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)

Benefits

• 25 days holiday (rising to 27 after year one and 30 after year three)
• 8 bank holidays
• Up to 5% employer matching pension contributions
• Private Healthcare Scheme
• Work-from-home options
• Cycle-to-work scheme
• Enhanced Maternity & Paternity Leave

About the company

Leafio is building a pharmaceutical supply chain to give pharmacies fast and reliable access to medicines. They are an ambitious, fast-growing business modernising pharmaceutical distribution.