Quality Assurance Engineer at Pharmathen Pharmaceuticals (Sapes)

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a QA Engineer to join our Quality Affairs LAI team based at Sapes Northern Greece premises.

As a QA Engineer, the ideal candidate will ensure compliance of equipment, applications and plant areas to GMP and ISO requirements.

What you will do:

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

The ideal candidate should have:

• Minimum of a Bachelor's Degree in Engineering
• At least 3 to 5 years of experience in the Pharmaceutical Industry

Job-Specific Skills:

• Excellent communication in English language (writing & speaking)
• Computer literacy
• Ability to prioritize tasks and meet deadlines
• Problem Solving Skills

For further information: Quality Assurance Engineer