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 attract a Quality Assurance Engineer to join our Quality Assurance Engineering & Qualification team at our Sapes premises.

As a Quality Assurance Engineer, you will keep a key role in all calibration / qualification activities of the site.

Requirements

More particularly:

What you’ll do:

• Issuance of TDR and SOPs relevant to operation, maintenance, cleaning and validation/ qualification activities of areas and equipment
• Compliance with legislation requirements regarding change controls, deviations, risk management related to equipment and areas
• Ensure compliance to the Quality Management System according to ISO 9001:2015 and EU cGMPs
• Responsible for the preparation and control of the controlled layouts of the plant and the warehouses
• Responsible for issuance, conducting and monitoring of protocols for validation and / or qualification of equipment, warehouses and production areas
• Keep a key role in project plans regarding new areas and equipment
• Carry out validation and / or qualification of equipment, applications and production areas and evaluate findings of measurements and studies, according to legislation and company’s standards
• Responsible for the training of production, warehouse and technical personnel related to the controls – measurements in regards to validation & qualification of equipment and plant areas
• Monitor the environmental conditions of production, quality control and warehouse areas, as well as, utilities
• Monitoring of maintenance activities of the facility and warehouses

Requirements

• BSc in Engineering or relevant field
• 1-3 years’ experience in an industrial environment is desirable

Job-Specific Skills

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

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