Qualified Person (m/f/d) as defined by §14 AMG (part-time, 25%)*

Job Posted 10/11/2024
Anonymous
Hesse
Frankfurt
Germany
Category Quality Control
Employee
Part-Time
Industry
Pharmaceutical
Job Description

Your Role

As a key member of our team, you will:

Ensure Product Quality and Compliance: Oversee batch release and certification processes, adhering to stringent EU and GMP standards, particularly for medical cannabis.
Monitor Quality Systems: Conduct rigorous testing and validation of manufacturing and testing procedures. Implement and manage deviation and change control processes, ensuring compliance with 19 AMG and 16 AMWHV.
Maintain Supplier Quality: Audit suppliers and contract manufacturers to verify adherence to GMP standards for cannabis production.
Prioritize Quality and Safety: Manage complaint investigations and conduct internal audits to identify and address quality and safety issues.
Document and Monitor: Maintain accurate and up-to-date release records in compliance with 19 AMG, and monitor operational processes according to 64 AMG.

Your Qualifications

We seek a highly skilled individual with:

Deep Regulatory Expertise: Proven experience in quality assurance and control within the cannabis medicine industry, with a strong understanding of Section 15 AMG.
Technical Proficiency: In-depth knowledge of EU GMP guidelines, MedCanG, and national regulations for medical cannabis.
Strong Analytical Skills: Ability to make sound decisions regarding quality assurance in complex manufacturing processes.
Excellent Communication Skills: Strong interpersonal skills and a collaborative approach to working with internal and external stakeholders.   
If you possess these qualities and are passionate about ensuring the highest standards of quality in medical cannabis, we encourage you to apply.
 

Employer

Berlin
Berlin
Germany
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