EU Qualified Person

The holder of this function is the 1st EU Qualified Person (Hauptverantwortliche Sachkundige Person) and will be responsible to fulfil the obligations as defined in European legislation.

The job holder will be responsible for overseeing the quality system, ensuring compliance with EU regulations, and serving as a key point of contact for authorities, ensuring the quality of our pharmaceutical products.

The qualification (education and experience) of the job holder must comply with the requirements as defined the German medicines law (AMG) and the EC Directive.

The ideal candidate will have a deep understanding of the quality systems and processes and possess excellent communication skills in both English and German.

In this role, your tasks will include:

To ensure that in the case of medicinal products manufactured within the EU, that each batch of medicinal products has been manufactured and tested in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization.

To ensure the quality of medicinal products in accordance with the requirements of the marketing authorization in the importing Member State in the case of medicinal products coming from third countries

To ensure that according to §§16-18 AMWHV and EUDRALEX Vol. 4 - Annex 16 for batch release certification, all requirements are fulfilled.

In addition, the Qualified Person has among other tasks that are laid out in the detailed job description to

·      Ensure that a quality management system is established and/or maintained which complies with applicable legal requirements.

·      Support health authority inspections and audits, ensuring readiness and compliance across all quality aspects.

§ Provide quality expertise and guidance to internal teams, stakeholders, and external partners. Liaise with Health Authorities, external partners, and internal stakeholders on quality-related matters

§ Provide quality training to internal teams and ensure staff are updated on the latest regulations and best practices

§ Develop, implement and update Quality SOPs and processes during company growth phase

§ Ensure correct application of Quality risk management process whenever necessary, selection of risk management methods and regular review of existing risk analyses.

§ Ensure that knowledge on current applicable legislation, products and manufacturing and testing processes for the job as Qualified Person is up-to date acc. §14 AMG.

Qualifications:

·      Relevant Life Science degree (Medical, Pharmacy, Nursing or equivalent)

·      A minimum of 10+ years of experience in quality, demonstrating a comprehensive skill set to a senior PV professional. The ideal applicant will possess extensive knowledge and expertise in all quality areas.

·      Experience supporting health authority inspections and knowledge of inspection processes.

·      Team management skills, strong logical, critical and problem-solving abilities

·      Fluent in English and German with excellent communication and interpersonal skills, and the ability to interact effectively with cross-functional teams.

·      Desirable: Experience in conducting and managing audits within the quality domain.

We offer:

• A unique opportunity to work in a lean and fast-paced company where you will be able to provide significant input to the quality department.
• A full time position.
• A competitive remuneration
• A dynamic and modern work environment
• Hybrid working environment, with a minimum of 2 days/week in company office in Lörrach, Germany 

CHEPLAPHARM is a family-owned company headquartered in Greifswald, Germany. For more than 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for manufacturing and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia, and Switzerland. The company employs around 650 people worldwide.

The affiliates in Switzerland and Lörrach, Germany were established in 2023 to further drive the growth of the group and global acquisitions of established medicines from large pharmaceutical companies.

Should you be interested in this position, please use the Linkedin link to apply with your CV.

Please note that we will only contact shortlisted applicants.

Disclaimer: Cheplapharm does not accept unsolicited CVs from recruiters or employment agencies in response to this posting.