For Employers
CMC Officer


101-250
Pharmaceutical & Health sector
a day ago
Posted date
a day ago
Mid-levelMinimum level
Mid-level
Full-timeEmployment type
Full-time

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 CMS Officer (at Polydendri site.)

            

           DUTIES AND RESPONSIBILITIES:

 

We are looking for a Chemistry, Manufacturing & Controls (CMS) Officer to join the team at our Product Development Dpt. The successful candidate will take on a challenging and demanding role with primary objective the compilation and review of the Common Technical Document (CTD) of pharmaceutical products.

Main responsibilities

  • Coordination, compilation and review of CTD of pharmaceutical products
  • Support during dossier assessment by competent authorities following strict timelines
  • Communication and close collaboration with laboratory and manufacturing site of the company in order to collect the required data for compilation of the CTD dossier
  • Support the transfer of the procedures to production
  • 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 2 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
Related tags
cmc sections
JOB SUMMARY
CMC Officer
Acharnes
a day ago
Mid-level
Full-time

CMC Officer