KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company that has been in operation in Greece for over 50 years. Kleva develops and manufactures generic products and focuses on Pharmaceuticals (Rx & OTC).

Our two manufacturing facilities in the North of Athens, Greece, are equipped with high technology machinery and have the manufacturing potential for a wide range of pharmaceutical forms.

Our mission is to offer a flexible, fully scalable, qualitative, and cost-effective product development in a wide range of dosage forms. We register and export our products to a number of regulated and non-regulated markets around the world.

To realize our ambitious goals, KLEVA needs people who are innovators, believe in the values of respect and cooperation and are ready to commit to a company that wants to penetrate new markets, leverage international business development opportunities, and enter contract manufacturing deals.

How you will support our mission

We are looking for a CMC Supervisor (at Polydendri site.)

       DUTIES AND RESPONSIBILITIES:

       The CMC Supervisor, reporting directly to Head of Product Development, is responsible for the preparation of Common Technical Document (CTD) of pharmaceutical products and in particular shall:

• Coordination on the compilation of the CTD dossiers
• Supervision of the implementation of the EU regulations and ICH guidelines in the compilation of the CTD dossiers
• Overseeing CMC-wise projects that are under development
• Design of regulatory strategy for dossier submission
• Coordination of the responses to questions raised during the assessment of the product dossier by the Authorities
• Coordination and collaboration with clients on the collection of documentation required for dossier submission
• Review of CTDs of pharmaceutical products
• Keep updated on regulations and guidelines published by competent authorities

PROFILE / SKILLS:            

Academic Background

• Bachelor’s degree in sciences (preferably Pharmacy or Chemistry)

Languages:

• Fluency in English both written and oral

Special Knowledge

• Excellent computer literacy (MS Office)

Qualifications 

• Previous professional experience of at least 5 years in a pharmaceutical company in the field of dossier compilation
• Be multitasking
• Cope with deadlines
• Excellent work in a team

Benefits

• Work in a friendly and challenging environment
• Competitive salary
• Private insurance
• Personal development opportunities