Bathera is a fast-growing international medical cannabis company operating across Germany, Portugal and Australia. As we continue to expand our operations, we are looking for an experienced Qualified Person (QP) to support our activities in Germany and ensure the highest standards of pharmaceutical quality and regulatory compliance.
About the Role
As a Qualified Person (QP), you will be responsible for ensuring that medicinal products are manufactured and released in compliance with applicable German and EU pharmaceutical legislation, Good Manufacturing Practice (GMP) requirements and relevant quality standards. Working closely with Quality Assurance, Production, Regulatory Affairs and international stakeholders, you will play a key role in maintaining product quality, patient safety and regulatory compliance.
Key Responsibilities
- Certify and release medicinal products in accordance with applicable German and EU pharmaceutical legislation.
- Ensure compliance with EU GMP guidelines and applicable regulatory requirements.
- Oversee batch documentation review and verify that manufacturing and quality control processes meet established standards.
- Support and maintain the Pharmaceutical Quality Management System (PQMS).
- Review and approve deviations, investigations, CAPAs and change controls, as required.
- Ensure compliance with Good Manufacturing Practice throughout manufacturing, testing, packaging and release activities.
- Collaborate with internal teams and external manufacturing and testing partners.
- Support regulatory inspections, audits and continuous improvement initiatives.
- Ensure that relevant quality documentation and records are accurate, complete and maintained in accordance with regulatory requirements.
Requirements
- Qualified Person status in accordance with applicable German pharmaceutical legislation, particularly § 15 AMG.
- Relevant university degree in Pharmacy, Chemistry, Biology or another eligible scientific discipline, as applicable under German law.
- Proven experience in pharmaceutical quality assurance, batch certification and product release within a GMP-regulated environment.
- Strong knowledge of EU GMP requirements and German pharmaceutical regulations.
- Experience in medical cannabis, herbal medicinal products or other relevant pharmaceutical products is highly desirable.
- Excellent communication and stakeholder management skills.
- Fluency in both German and English, written and spoken, is essential.
- Ability to work independently while collaborating effectively with international teams.
What We Offer
- The opportunity to join a growing international medical cannabis company.
- A key role in ensuring product quality, patient safety and regulatory compliance.
- A dynamic, international working environment.
- Opportunities to contribute to the development and continuous improvement of quality processes. Competitive remuneration, commensurate with experience and qualifications.
#J-18808-Ljbffr
