Overview
Quality Assurance Senior Officer – Biotechnology Jobs in Athens, Attiki, Greece at DEMO Pharmaceuticals S.A.
Title: Quality Assurance Senior Officer – Biotechnology
Company: DEMO Pharmaceuticals S.A.
Location: Athens, Attiki, Greece
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
Requirements
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
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
