Remote-Eligible Pharma Quality Assurance Lead – GDP & Compliance

Montu UK; Winnersh; Hybride; GBP 52 000 - 70 000; Plein temps

Avantages offerts par ce poste

25 days holiday

Pension matching 5%

Private healthcare scheme

Work-from-home options

Cycle-to-work scheme

Enhanced parental leave

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GDP/GMP knowledge

Regulatory compliance

QMS/Deviations/ CAPAs

Attention to detail

Audit & inspection support

Outils

ERP system

Description du poste

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.