At DEMO SA, one of the world's largest pharmaceutical manufacturers in injectable facilities, we are excited to kick-off our Biotechnology project in Athens.

The field of Biotechnology is bringing about fascinating developments in medicine, treatments, and healthcare, as new, effective medicines are being produced from extremely complex natural compounds, with a biological origin. Demo leads the way in the Greek pharmaceutical market with major investments in Biotechnology.

• We are building a prototype unit for the development of monoclonal antibodies

• We are creating a contemporary Research and Development Center for biotechnology

• We are starting research for three finished pharmaceutical products with monoclonal antibodies

• We are establishing a Biotechnology Academy to train young scientists. Biotechnology is becoming part of our lives.

As a result, we are currently looking for a motivated Quality Assurance Senior Officer to grow with us and join our team.

Main duties and responsibilities:

• Contributes to the set-up, implementation and improvement of QMS and verifies the company’s compliance with cGMP quality system requirements as well as Good Manufacturing Practices.

• Provides immediate support to operations and quality control staff to address compliance related concerns.

• Makes independent quality-related decisions based on regulatory and compliance knowledge.

• Provides oversight for compliance of CAPA and investigations, OOS and deviations.

• Writes/revises master documents, Forms, Standard Operating Procedures (SOPs), specifications, etc. within the DEMO document management system.

• Creates new documents such as SOPs and other supportive documents within the DEMO document management system.

• Performs project related tasks as assigned.

• Preparation and monitoring of validation master plan for the new Bio sector.

• Continuous collaboration and communication with other departments within DEMO.

• Uses Risk Management tools when required.

• Continuous EU-GMP and USFDA regulations monitoring and compliance.

·         Bachelor Degree in Biology, Biotechnology, Chemical Engineering, or relevant field. MSc in any of these fields will be a competitive advantage

·         Professional experience of more than 3 years in QA sector in Pharmaceutical and/or Biotechnology industry is required.

·         Experience with pharmaceutical Quality Systems including change control, deviation and CAPA

·         Prior experience with SAP, Trackwise and LIMS is a plus

·         Fluency in English, oral and written

·         Ability to build effective relationships with internal customers and supporting functions such as QC, QA, Engineering and Operations

·         Resilience & ability to articulate complex information concisely

The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.