Technology Transfer GMP Compliance Officer

Sapes, East Macedonia and Thrace, Greece

Pharmathen

Pharmathen is a research-centered, pharmaceutical company which focuses in developing innovative generic products. Pharmathen is providing a complete package of integrated services including finished products, know-how, and technological and...

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Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.

Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.

Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a Technology Transfer GMP Compliance Officer to join our Technology Transfer team at Pharmathen’s Sapes premises.

As a Technology Transfer GMP Compliance Officer, you will prepare the GMP documents of Technology Transfer Department such as change controls, deviations and OOS observed before/during analytical and manufacturing processes by collecting the required information and investigating wherever applicable or by coordinating the investigation team. 

More particularly:

What you’ll do:

  • Be responsible for keeping up to date the change controls, Deviation and OOS report of Technology Transfer Department
  • Prepare deviation and OOS reports and is member of the investigation team to decide for corrective actions analytical and/or process optimization ways
  • Co-ordinate multi department actions/investigations if required for change controls, deviations, OOS
  • Carry out literate search in regard to the analytical results’ deviations and/or OOS
  • Assist any other documentation work/review of Technology Transfer Department if required

Requirements

The ideal candidate should have:

  • Minimum an BSc Degree in Chemistry or relevant field
  • At least 2 years of experience in pharmaceutical quality units
  • Experience in a GMP or GLP environment

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Competent in laboratory instrumentation (e.g., HPLC, GC, dissolution).
  • Manufacturing process understanding
  • Strong problem solving skills
  • GMP/GLP and biopharmaceuticals experience preferred

Benefits

What you'll gain:

  • Involvement in a high-caliber, team-oriented and dynamic atmosphere
  • Exposure to challenging business issues and practices
  • Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career!

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.

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Tags: Compliance R&D

Perks/benefits: Career development Startup environment

Region: Europe
Country: Greece
Job stats:  1  0  0
Category: Compliance Jobs

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