Montu UK is hiring for the role of Qualified Person at our Winnersh, England location. Join us to ensure compliance with legal and regulatory standards in medical cannabis production.
Role Overview
The Qualified Person (QP) oversees quality systems, GMP compliance, and batch certification to maintain product integrity and patient safety. The role involves preparing for licensing processes and acting as Responsible Person (RP) across the business.
Key Responsibilities
* Batch Certification & Release: Certify and release medical cannabis batches according to EU GMP and local standards (e.g., MHRA). Review related documentation.
* Supplier Qualification & Auditing: Ensure GMP compliance through qualification and audits.
* Regulatory Compliance: Maintain adherence to local laws (e.g., Misuse of Drugs Regulations). Liaise with authorities during inspections.
* Quality Assurance: Lead QMS activities including CAPAs, deviations, and risk assessments. Conduct supplier audits.
* SOP Management: Oversee SOP creation, approval, and training. Monitor adverse events and collaborate with teams to ensure quality across the supply chain. Provide training on quality and compliance.
Qualifications & Requirements
* Legally recognized Qualified Person status under applicable regulations.
* Degree in pharmacy, chemistry, biology, or related field.
* Extensive GMP knowledge, especially for medicinal cannabis.
* Experience in GMP-regulated pharmaceutical or cannabis environments.
* Strong understanding of quality systems, regulatory submissions, and product release.
* Attention to detail, documentation skills, and regulatory awareness.
* Ability to manage projects and work under deadlines.
Preferred Experience
* Experience in the medical cannabis industry.
* Familiarity with controlled drug handling and record-keeping.
* Interaction with regulatory agencies (e.g., HPRA, MHRA, EMA).
About Montu
Montu is a leading UK cannabis company focused on improving patient access and care through innovative ecosystems and supply chain management. Our mission is to enhance lives via cannabis therapies, leveraging technology and industry expertise.
Additional Details
* Seniority Level: Mid-Senior level
* Employment Type: Full-time
* Job Function: Administrative, Distribution, and Quality Assurance
* Industry: Healthcare
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