Quality Assurance Engineer

2 days ago

Pallini, Attica, Greece Pharmathen Full time €35,000 - €60,000 per year

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 for the Quality team of our Pallini site.

As a Quality Assurance Engineer, you will ensure compliance with equipment, processes and plant areas to cGMPs requirements, ISO standards and VMP requirements. You will participate in new areas and equipment projects as per quality demands and responsible for areas design and qualifications and instrument/equipment calibration/ qualification activities. You will also be responsible for customer communication regarding engineering topics and interdepartmental communication.

More particularly:

What you will do:

  • Issuance/ review 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 with 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
  • Work closely with other engineering teams, product management, and operations to ensure seamless integration of quality practices throughout the product development lifecycle
  • Participate in project plans regarding new areas and equipment and communicate internally as well as with the subcontractors
  • 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 the external warehouses
  • Execute, monitor and control the internal Validation/Qualification/ Calibration procedures of the equipment/premises, utilities and production areas and evaluates findings of measurements and studies, according to legislation and company's standards
  • Participation in customer audits, authorities' inspections as well as self-inspection
  • Participate in all calibration/ qualification activities of the site and the external warehouses
  • Participate in troubleshooting regarding technical issues of the site and the external warehouses

Requirements

The ideal candidate should have:

  • Educational background in Engineering or relevant field
  • Desirable 1-3 years of relevant experience in an industrial environment

Job-Specific Skills:

  • Excellent communication in English language (writing & speaking)
  • Broad knowledge and extensive experience on pharmaceutical quality systems of aseptic manufactured products (injectable sterile products as powders or liquids)
  • Extensive knowledge of European GMPs to be able to ensure compliance with national and European standards and legislation
  • Computer literacy
  • Ability to prioritize tasks and meet deadlines

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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