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

Essence Investment AG; Weimar; Hybrid; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Thuringia seeks a Qualified Person (QP) to ensure pharmaceutical quality and regulatory compliance for medicinal cannabis. This role involves certifying batch releases, maintaining GMP compliance, and leading audits. Candidates should possess a pharmacy degree, 3-5 years of GMP experience, and fluent German. The position offers onsite or hybrid work in Erfurt with a supportive team environment.

Leistungen

Professional and supportive team

Onsite or hybrid work possible

Working with cannabis industry leaders

Qualifikationen

• Eligibility as a Qualified Person under §14 AMG.
• 3–5 years of GMP experience, ideally with herbal medicinal products.
• In-depth knowledge of EU-GMP, GDP, AMG, BtMG, and BtMVV.

Aufgaben

• Certify and release medicinal cannabis batches.
• Maintain oversight of GMP and GDP compliance.
• Prepare for and support regulatory inspections.
• Ensure accurate documentation in line with EU-GMP standards.
• Provide pharmaceutical oversight across operations teams.

Kenntnisse

Batch certification

Regulatory compliance

Analytical skills

Fluent German

Strong English proficiency

Ausbildung

University degree in pharmacy or life sciences

Jobbeschreibung

Portfolio company - AMP

About us

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.

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

1. 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.

2. Compliance & Quality Assurance

• 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.

3. Audits & Inspections

• 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.

4. Documentation & Quality Systems

• 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.

5. Leadership & Cross-Functional Collaboration

• 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