Qualified Person (QP)Location: Densborn, Germany. (Three days a week in the Office required)Industry: Pharmaceutical & Medical Cannabis IndustryCompany Overview:Our client is a leading German distributor of pharmaceutical and medical cannabis products and a subsidiary of one of North America's largest medical cannabis companies. Founded in the 1990s, they have established a strong reputation for delivering high-quality pharmaceuticals, including medicinal cannabis, to pharmacies and healthcare institutions across Germany. Their unwavering commitment to excellence in pharmaceutical manufacturing and distribution, coupled with stringent adherence to regulatory standards, has positioned them as a trusted partner in the German healthcare industry. The parent company, one of the world’s largest in the medical cannabis sector, employs over 500 people globally. In Germany, our client has a dedicated team of over 100 employees, with 50 in the Quality/Reg Affairs team. You will report to the Director of Quality.Job Summary:The QualifiedPerson (QP) plays a critical role for the client, responsible for ensuring that allmedicinal products meet the necessary quality standards before they are released for sale or supply. The QP will work closely with various departments to maintain compliance withpharmaceutical regulations, ensure proper documentation, and oversee quality controlprocesses. This role is essential in safeguarding patient safety and upholding the company’s reputation for excellence.Key Responsibilities:Regulatory Compliance: Ensure compliance with all relevant pharmaceutical regulations, from manufacturing to testing to the release of products before placement on the market.Batch Release: Provide written confirmation with a date and personal signature for the proper manufacture of each batch of medicinal products, including labeling and ensuring the presence of the package insert.Supplier Qualification: Participate in the selection and monitoring of medicinal product suppliers, including conducting on-site audits, and approving suppliers following supplierqualification procedures.Contract Manufacturer and Freight Forwarder Approval: Approve the commissioning of contract manufacturers and freight forwarders, review supplier documents, and authorize product release.Quality Review: Review pharmaceutical-technical complaints related to manufacturing, packaging, storage, returns, and complaints management.GMP Compliance: Review and approve GMP-relevant Standard Operating Procedures (SOPs) and oversee the qualification of GMP-relevant rooms, including storage and manufacturing areas.Deviation Management: Review and manage deviations from standard procedures, ensuring corrective actions are implemented.Product Quality Reviews: Prepare and evaluate Product Quality Reviews, ensuring continuous product quality, and prepare the Site MasterFile.Pharmaceutical Consultation: Serve as the key contact person for pharmaceutical-related questions within the organization.Continuous Improvement: Work collaboratively with other departments to identify and implement continuous improvement opportunities within the quality management system.Qualifications and Experience:Qualified Person Certification: Must hold certification as a Qualified Person (QP) by EU regulations with practical experiance.Knowledge: In-depth knowledge of EU GMP guidelines, regulatory requirements, and pharmaceutical manufacturing processes.Analytical Skills: Strong analytical and problem-solving skills with a keen attention to detail.Communication: Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and external partnersLanguages: Fluent in German & Conversational English is requiredA certificate of good conductProof of expertise according to § 15 AMGGood knowledge of current legislation (AMG, AMWHV, GMP rules, GDP)Compensation + Benefits:Up to 110,000 Euros base depending on experienceAll Legal German BenefitsHybrid working modelIf this role sounds interesting, then please apply through this site or email me your CV at aj.mishra@luminorecruit.com. Referral fees are available.Note: Applicants must be based in Germany and have the right to work in the EU