Sapes, East Macedonia and Thrace, Greece
3 days ago
Quality Assurance Engineer (Rodopi)

Founded in 1969, Pharmathen has grown to become one of the largest, vertically integrated developers of complex drug delivery technologies and is among the top 50 pharmaceutical research companies in Europe.

The company has one of the most extensive and advanced pipelines of long acting injectables (LAI), sustained release and ophthalmic formulations.

Pharmathen’s highly diversified portfolio consists of over 90 commercialized products, which are produced in its US FDA and EU-approved manufacturing facilities in Greece, serving 250 customers and accessed by patients in more than 90 countries worldwide.

Pharmathen proudly employs more than 1,600 people from over 28 different nationalities, with 54% of its total workforce and 66% of its Research Operations Team being female. The company’s enduring success is attributed to a passion for creativity, strong ethics, and the dedication of its people, who share a commitment to 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 recruit a Quality Assurance Engineer to join the Quality Engineering & Qualification team in our Sapes premises.

As a Quality Assurance Engineer, the ideal candidate will ensure compliance of equipment, applications and plant areas to EU cGMPs and ISO requirements.

More particularly:

What you will do:

Handle the technical application of GMP requirements in the facility Ensure compliance to the Quality Management System System’s Requirements according to FDA regulations, EU-GMP regulation to ISO 9001 and 14001 Preparation, revision and maintenance of drawings. Preparation, execution, review and monitoring of the protocols, that will be used for validation and / or qualification of Equipment, Systems of production and Utility Carry out validation and / or qualification of equipment, systems and production areas and ensure activity is successfully completed as per approved study protocols. Participate in computer system validation for manufacturing equipment Responsible for periodic performance requalification of equipment, systems of production areas and for the correct application of Validation Master Plan Monitor the status labelling and calibration of the equipment and follow up of preventive maintenance and calibration plans Handle the training of technical personnel related to the controls – measurements in regard to validation & qualification of equipment and plant areas Monitor the environmental conditions (temperature, humidity) for cold rooms and storage areas. Participate in media-fill simulation process in aseptic manufacturing area
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