AMP is an established pharmaceutical wholesaler, importer, distributor, and manufacturer in the German medical cannabis sector, operating in full alignment with EU‑GMP and GDP standards. Based in Thuringia, we manage high‑quality medicinal cannabis products sourced from international partners and ensure compliant processing, packaging, and distribution throughout Germany.

Role Overview

We are looking for a Qualified Person (QP) authorised to bear legal responsibility under 14 AMG for ensuring the pharmaceutical quality and regulatory compliance of all medicinal cannabis batches processed, imported, manufactured, or distributed by the company. This includes batch certification, oversight of GMP/GDP processes, and close collaboration with regulatory authorities and external partners.

Responsibilities

Batch Certification & Release
Certify and release medicinal cannabis batches in accordance with AMG, EU‑GMP Part I & II, and Annex 16
Review and approve batch documentation, including BMR/BPR, deviation reports, CoAs, and stability data
Ensure imported cannabis batches meet EU‑GMP requirements, including oversight of third‑country manufacturers
Confirm compliance with narcotics regulations (BtMG, BtMVV) for all released batches
Maintain oversight of GMP and GDP compliance throughout manufacturing, packaging, storage, and distribution
Approve and maintain QMS documents including SOPs, validation protocols, and work instructions
Manage deviation, CAPA, and change control processes
Support qualification and monitoring of suppliers, CMOs, and testing laboratories
Prepare for and support regulatory inspections from authorities such as Regierungspräsidium and BfArM
Conduct internal audits and audits of international cannabis suppliers and contract manufacturers
Lead follow‑up activities arising from audits and inspections
Ensure accurate documentation in line with EU‑GMP Annex 11 & 15
Approve PQR/APR reports and oversee stability management
Evaluate and resolve OOS/OOT results in collaboration with laboratories
Provide pharmaceutical oversight across operations teams including QA, Manufacturing, Supply Chain, and RA
Support regulatory submissions and updates
Serve as the primary quality authority for internal and external stakeholders

Requirements

Eligibility as a Qualified Person under 14 AMG
University degree in pharmacy or other accepted life sciences with QP recognition
3‑5 years of GMP experience in pharmaceuticals, ideally involving herbal medicinal products or medical cannabis
Experience with batch certification, QMS processes, and regulatory interactions
In‑depth knowledge of EU‑GMP, GDP, AMG, BtMG, and BtMVV
Strong analytical and decision‑making skills
Fluent German (C1+) and strong English proficiency

Preferred Qualifications

Experience in medical cannabis import, testing, or cultivation
Familiarity with international regulatory frameworks (e.g., Canada, Israel, Australia)
Prior involvement in EU‑GMP inspections abroad

Benefits

Working with one of the cannabis industry leaders in Germany
Professional and supportive team
Onsite or hybrid work is possible (2 days a week in the office)
Office location in Erfurt

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Other

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Essence Investment AG

Jobs:

Qualified Person (QP) / Sachkundige Person (Article 14 AMG)

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